Public recall detail

Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay

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Recall Safety notice
Quick summary

Quick summary: Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay.

Recommended action

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

Recall details

Quick summary: Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay.

Official details

Affected product details

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

BrandSiemens Healthcare Diagnostics Products Limited
ProductImmulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay
IssueMedical devices - Inaccurate test or measurement results
Recall classType II
IdentificationRA-64028

Affected products

ProductImmulite 2000 System-Human Chorionic Gonadotropin (Hcg) Assay
Lot466, 463
ModelL2KCG2, L2KCG6
Serial number466, 463
DescriptionImmulite 2000 System-Human Chorionic Gonadotropin (Hcg) Assay

Issue

Siemens Healthcare Diagnostics Inc. has confirmed the potential for falsely elevated hcg results due to sample carryover. This can be observed when a sample is assayed for HCG immediately after an undiluted sample with a HCG value of GT;5000 MIU/mL. This issue impacts serum and urine patient samples, as well as quality control samples and adjustors. The effect of carryover varies based on the concentration of the high HCG sample. Recall start date: Mar 1, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Chemistry
CompaniesSiemens Healthcare Diagnostics Products Limited Glyn Rhonwy, Llanberis, Gwynedd Great Britain, LL55 4EL
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64028
Background{}
CompaniesSiemens Healthcare Diagnostics Products Limited Glyn Rhonwy, Llanberis, Gwynedd Great Britain, LL55 4EL
AudiencesGeneral public Health professionals Hospitals
Source updated2022-03-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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