Product Wiki · Recalls · Health Canada — Medical Devices

ACCESS SYSTEM & UNICEL DXI 600/800 ACCESS IMMUNOASSAY SYSTEM — recall 61606

Health Canada — Medical Devices · Canada · 2020-09-18 · Type II

As described by Health Canada — Medical Devices: ACCESS SYSTEM & UNICEL DXI 600/800 ACCESS IMMUNOASSAY SYSTEM - UNCONJUGATED ESTRIOL ASSAY (2020-08-31)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
61606
Date of alert
2020-09-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Customer feedback has helped Beckman Coulter identify and characterize the potential for higher than expected Bovine-ALP associated interference in patient samples tested with the access uE3 assay, for the affected lots. An internal investigation of ~300 samples confirmed that up to 3% of patient samples may demonstrate Bovine-ALP associated interference. The frequency and mechanism of Bovine-ALP associated interference is specific to the access uE3 assay. This interference is not associated with patient sample endogenous ALP levels. Based on the internal investigation performed on ~300 samples, Bovine-ALP associated interference could increase serum sample uE3 concentrations by: a mean of 50% (range 33%-77%) in samples with uE3 concentrations >1.5 ng/mL. a mean of 0.53 ng/mL (range 0.42-0.70 ng/mL) in samples with uE3 concentrations ?1.5 ng/mL. A falsely elevated uE3 test result can lead to inaccurately classifying the relative risk of chromosomal anomalies-such as trisomy 21 and 18-in patient samples undergoing triple and quad prenatal screening. Second trimester prenatal screening includes Alpha-fetoprotein (AFP), Human chorionic gonadotropin (hCG), unconjugated estriol (uE3) and inhibin A. Only uE3 is affected by the issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/access-system-unicel-dxi-60080

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.