Public recall detail

Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - II (2014-10-10)

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Recall Safety notice
Quick summary

Quick summary: Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - II (2014-10-10) .

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Various Dimension Chemistry, Clinical Chemistry, EXL and XP System Products - II (2014-10-10) .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

Affected products

Description1) Dimension Clinical Chemistry System-ALP/Alkaline Phosphatase Lot or serial number Not applicable Model or catalog number DF15A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 2) Dimension Clinical Chemistry System -Revised Amylase Lot or serial number Not applicable Model or catalog number DF17A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 3) Dimension Chemistry System - Troponin I Lot or serial number Not applicable Model or catalog number DF73 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 4) Dimension Clinical Chemistry System -ALB/Albumin Lot or serial number Not applicable Model or catalog number DF13 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 5) Dimension Clinical Chemistry System -Total Iron Binding Capacity (TIBC) Lot or serial number Not applicable Model or catalog number 10444944 and DF84 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 6) Dimension Clinical Chemistry System -Complement C3 Flex Reagent Lot or serial number Not applicable Model or catalog number DF101 and DF102 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 7) Dimension Clinical Chemistry System -Transferrin Reagent Cartridge Lot or serial number Not applicable Model or catalog number DF103 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 8) imension Clinical Chemistry System-Enzymatic Carbonate Flex Reagent Lot or serial number Not applicable Model or catalog number 10444975 and DF137 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 9) Dimension Clinical Chemistry System -lithium flex reagent cartridge Lot or serial number Not applicable Model or catalog number DF132 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 10) Dimension Xpand System-Enzymatic Carbonate Flex Reagent Lot or serial number Not applicable Model or catalog number 10444972 and DF137 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 11) Dimension Xpand System-Human Chorionic Gonadotropin Flex (IHCG) Lot or serial number Not applicable Model or catalog number RF530 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 12) Dimension Xpand System-ITNI Cardiac Troponin I Flex Reagent Lot or serial number Not applicable Model or catalog number 10444905, RF421C and RF521 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 13) Dimension xpand system-Immb Mass Creatine Kinase MB Isoenzyme Flex Assay Lot or serial number Not applicable Model or catalog number 10444904 and RF520 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 14) Dimension Chemistry System -(FPSA) Free Prostate Ppecific Antigen Flex Reagent Lot or serial number Not applicable Model or catalog number RF452 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 15) Dimension Chemistry System -(TPSA) Total Prostate Specific Antigen Flex Reagent Lot or serial number Not applicable Model or catalog number RF451 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 16) Dimension Clinical Chemistry System -LDL Choloesterol Flex Reagent Cart. (ALDL) Lot or serial number Not applicable Model or catalog number DF131 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 17) Dimension Clinical Chemistry System -Glucose Flex Reagent Cartridge (Gluc) Lot or serial number Not applicable Model or catalog number DF40 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 18) Dimension Clinical Chemistry System -Urine Amphet./Methamphet. Screen Flex Lot or serial number Not applicable Model or catalog number DF91B Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 19) Dimension Clinical Chemistry System-Microalbumin Flex Reagent Cartridge (MALB) Lot or serial number Not applicable Model or catalog number 10444896, 10444905, RF421C and RF521 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 20) Dimension EXL System-Cardiac Troponin-I(CTNI) Assay Lot or serial number Not applicable Model or catalog number 10444896, 10444905, RF421C and RF521 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 21) Dimension EXL System -Free PSA (FPSA) Assay Lot or serial number Not applicable Model or catalog number 10444888 and RF452 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 22) Dimension EXL System -Mass Creatine Kinase MB Isoenzyme (MMB) Assay Lot or serial number Not applicable Model or catalog number 10444895, 10444904, RF420 and RF520 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 23) Dimension EXL System -Myoglobin (MYO) Assay Lot or serial number Not applicable Model or catalog number 10444907 RF422A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 24) Dimension EXL System - N-terminal Pro-Brain Natriuretic Peptide (PBNP) assay Lot or serial number Not applicable Model or catalog number 10444901 RF423A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 25) Dimension EXL System -Tacrolimus (TACR) Assay Lot or serial number Not applicable Model or catalog number 10444938 DF107 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 26) Dimension EXL System -Total PSA (TPSA) assay Lot or serial number Not applicable Model or catalog number 10444889 RF451 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 27) Dimension EXL System - Creatine Kinase Flex (CKI) assay Lot or serial number Not applicable Model or catalog number 10464511 DF38 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 28) Dimension EXL System - Lactate Dehydrogenate (LDI) Assay Lot or serial number Not applicable Model or catalog number 10284483 DF54 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 29) Dimension XP and System- Creatine Kinase Flex (CKI) assay Lot or serial number Not applicable Model or catalog number 10464511 DF38 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 30) Dimension XP and System - Lactate Dehydrogenate Flex (LDI) Lot or serial number Not applicable Model or catalog number 10284483 DF54 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 31) Dimension Clinical Chemistry System-Creatine Kinase Flex (CKI) assay Lot or serial number Not applicable Model or catalog number 10464511 and DF38 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 32) Dimension Clinical Chemistry System -Lactate Dehydrogenate Flex (LDI) Lot or serial number Not applicable Model or catalog number 10284483 DF54 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 33) Dimension Clinical Chemistry System.- automated HDL cholesterol (AHDL) assay Lot or serial number Not applicable Model or catalog number 10464332 DF48B Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 34) Dimension XP and System-automated HDL cholesterol (AHDL) assay Lot or serial number Not applicable Model or catalog number 10464332 DF48B Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 35) Dimension EXL System-automated HDL cholesterol (AHDL) Assay Lot or serial number Not applicable Model or catalog number 10464332 DF48B Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 36) Dimension Chemistry Ssystem-Creatine Kinase MB (MBI) Assay Lot or serial number Not applicable Model or catalog number 10464510 DF32 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 37) Dimension XPL and System-Creatine Kinase MB (MBI) Assay Lot or serial number Not applicable Model or catalog number 10464510 DF32 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 38) Dimension EX Lsyste,- Creatine Kinase MB (MBI) Assay Lot or serial number Not applicable Model or catalog number 10464510 DF32 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 39) Dimension XP and System-Total Iron Binding Capacity (IBCT) Asay Lot or serial number Not applicable Model or catalog number 10444944 DF84 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 40) Dimension EXL System- Total Iron Binding Capacity (IBCT) Asay Lot or serial number Not applicable Model or catalog number 10444944 DF84 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 41) Dimension XP and System-Acetominophen (ACTM) assay Lot or serial number Not applicable Model or catalog number 10444916 DF88 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 42) Dimension XP and System-Albumin (ALB) Assay Lot or serial number Not applicable Model or catalog number 10444975 DF13 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 43) Dimension XP and system-Ethyl Alcohol (ACL) Assay Lot or serial number Not applicable Model or catalog number 10444917 DF18 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 44) Dimension XP and System -Automated LDL (ALDL) Cholesterol assay Lot or serial number Not applicable Model or catalog number 10444890 DF131 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 45) Dimension XP and System -Alanine Aminotransferase (ALT) Assay Lot or serial number Not applicable Model or catalog number 10444958 10475530 DF143 DF43A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 46) Dimension XP and System -Ammonia (AMON) Assay Lot or serial number Not applicable Model or catalog number 10444954 DF19 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 47) Dimension XP and System -Urine Amphetamine/Methamphetamine (AMPH) Lot or serial number Not applicable Model or catalog number 10444926 DF91B Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 48) Dimension XP and System -Amylase (AMY) Assay Lot or serial number Not applicable Model or catalog number 10444965 DF17A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 49) Dimension XP and System -Aspartate Aminotranspherase (AST) Assay Lot or serial number Not applicable Model or catalog number 10444959 DF41A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 50) Dimension XP and System -Urine Bariturate (BARB) Screen Lot or serial number Not applicable Model or catalog number 10444918 DF96A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 51) Dimension XP and System -Urine Benzodiazepines (BENZ) Screen Lot or serial number Not applicable Model or catalog number 10444919 DF97A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 52) Dimension XP and System -Urea Nitrogen (BUN) Assay Lot or serial number Not applicable Model or catalog number 10444969 DF21 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 53) Dimension XP and System -Complement C3 Assay Lot or serial number Not applicable Model or catalog number 10444981 DF101 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 54) Dimension XP and System -Complement C4 Assay Lot or serial number Not applicable Model or catalog number 10444981 DF102 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 55) Dimension XP and System-Calcium (Ca) Assay Lot or serial number Not applicable Model or catalog number 10444949 DF23A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 56) Dimension XP and System -Cardio Phase High Sensitivity CRP (CCRP) Lot or serial number Not applicable Model or catalog number 10444897 RF434 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 57) Dimension XP and System -Cholesterol (CHOL) Assay Lot or serial number Not applicable Model or catalog number 10444891 DF27 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 58) Dimension XP and System -Urine Cocaine (COC) Metabolite Screen Lot or serial number Not applicable Model or catalog number 10444920 DF92A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 59) Dimension XP and System -Carbamazapine (CRBM) Assay Lot or serial number Not applicable Model or catalog number 10444930 DF87 Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES 60) Dimension XP and System -Creatinine (CREA) Assay Lot or serial number Not applicable Model or catalog number 10444968 DF33A Companies Manufacturer Siemens Healthcare Diagnostics Inc. 500 GBC Drive, Mailstop 514, PO Box 6101 Newark 19714-6101 Delaware UNITED STATES
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