Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA Chemistry Creatine Kinase (2019-05-15) — recall 59190

Health Canada — Medical Devices · Canada · 2019-05-31 · Type III

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
59190
Date of alert
2019-05-31
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has confirmed increased incidences of system generated (u,u) flags on calibration, quality control and patient results when using the ADVIA Chemistry Creatine Kinase (CK_L) reagent kit lots 465336, 465663, and 468449 on the ADVIA 1800, 2400, and XPT Chemistry Systems. As per the ADVIA Chemistry Systems operators guide, samples with u or u flags are not to be reported. Siemens has also confirmed for the affected lots that patient results may be falsely decreased or increased across the analytical range even when the u flags are not generated.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-chemistry-creatine-kinas

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.