Product Wiki · Recalls · Health Canada — Medical Devices

ORTHO VISION Analyzer (2015-10-07) — recall 54451

Health Canada — Medical Devices · Canada · 2015-10-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54451
Date of alert
2015-10-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Ortho Clinical Diagnostics, Inc. (OCD) initiated this recall due to the potential for used dilution wells to be reused. Reuse of dilution wells can occur if: an OCD field engineer performs a clean-up of the analyzer database, or if an operator restores a database backup on the analyzer and, dilution trays have not been removed from the instrument prior to restarting the system. In this situation, the analyzer software cannot identify usage history of the dilution wells on the instrument, and reuse of wells may occur.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ortho-vision-analyzer-2015-10-

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.

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