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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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
Get notified
Receive notifications for new and updated recalls and alerts by category.