Health product recall

Immulite 2000 System-Human Chorionic Gonadotropin (Hcg) Assay

Last updated

Summary

Product
Immulite 2000 System-Human Chorionic Gonadotropin (Hcg) Assay
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Immulite 2000 System-Human Chorionic Gonadotropin (Hcg) Assay

466, 463

L2KCG2, L2KCG6

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

Additional information

Details
Original published date: 2022-03-31
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy, Llanberis, Gwynedd

Great Britain, LL55 4EL

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64028