Product Wiki · Recalls · Health Canada — Medical Devices

COBAS LIAT ANALYZER (2017-10-24) — recall 57846

Health Canada — Medical Devices · Canada · 2017-11-24 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
57846
Date of alert
2017-11-24
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: A situation was identified where the cobas Liat analyzer was manufactured and distributed with 3 assay scripts pre-loaded on the instrument. One of the assay script (cobas Liat Strep A) is not yet licenced in Canada. However, there is no user-impact since the assay is not available in Canada and is not functional on the analyzer leading to no consequence on result reliability.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-liat-analyzer-2017-10-24

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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.