Product Wiki · Recalls · Health Canada — Medical Devices

Cobas P612 and P512 Pre-Analytical Systems (2017-05-31) — recall 56699

Health Canada — Medical Devices · Canada · 2017-06-21 · 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
56699
Date of alert
2017-06-21
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Following internal investigation, the manufacturer identified a situation where under specific conditions, there is a possibility that un-spun samples could be incorrectly identified as spun by the spin status detection configuration of the Cobas P512-P612 pre-analytical system when used in combination with dynamic interface system.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cobas-p612-and-p512-pre-analyt

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.