Back to RecallTracker
Health Canada Medical devices

Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay

Issued March 28, 2022
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
Hazard description
Inaccurate test or measurement results
Product
Product name
Immulite 2000 System-Human Chorionic Gonadotropin (HCG) Assay
Reference
ID
RA-64028