Quick summary
Quick summary: GEM PAKs for the GEM Premier 5000 with iQM2. Reason: Performance. Category: Chemistry. Date: 2026-03-17.
Public recall detail
GEM PAKs for the GEM Premier 5000 with iQM2
2026-03-17
Chemistry
Performance
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: GEM PAKs for the GEM Premier 5000 with iQM2. Reason: Performance. Category: Chemistry. Date: 2026-03-17.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandINSTRUMENTATION LABORATORY CO.
ProductGEM PAKs for the GEM Premier 5000 with iQM2
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81732
Affected products
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055415004
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055430004
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055445004
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055430011
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055415011
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055360008
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055407508
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055415008
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055445008
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055430008
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055415010
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055430010
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055407510
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055360010
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
ProductGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
LotMore than 10 numbers, contact manufacturer.
Model00055445010
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionGem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2
Issue
The company confirmed customer complaints indicating that specific GEM PAKs (cartridges) for the Gem Premier 5000 may experience an increased incidence of "Process Control Solution Not Detected" (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying appropriate patient management. In such cases, patient management may require reassessment once results are available. While many GEM PAK s continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
What you should do
- Contact the manufacturer if you require additional information. CONTACT WERFEN TECHNICAL SUPPORT AT 1-800-678-0710
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443
Recall date2026-02-25
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81732
Background{}
CompaniesInstrumentation Laboratory Co. 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443
AudiencesHealthcare
Source updated2026-03-17
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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