Product Wiki · Recalls · Health Canada — Medical Devices

Immage Immunochemistry Systems Rheumatoid Factor Reagent — recall 49312

Health Canada — Medical Devices · Canada · 2012-12-24 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
49312
Date of alert
2012-12-24
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: During Beckman Coulter Inc (BEC) internal real-time stability testing, some lots of RF reagent showed calibration failure before the currently labeled shelf life. Although some lots have passed real-time stability testing, to be conservative, the expiration dating of all in-date and in-process lots is being shortened.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immage-immunochemistry-systems

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