Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay
Summary
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
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy, Llanberis, Gwynedd
Great Britain, LL55 4EL