Product Wiki · Recalls · Health Canada — Medical Devices

Immage Immunochamistry Systems Apolipoprotein A-1 (APA) and Beckman… — recall 52963

Health Canada — Medical Devices · Canada · 2014-12-29 · Type III

As described by Health Canada — Medical Devices: Immage Immunochamistry Systems Apolipoprotein A-1 (APA) and Beckman Coulter Clinical Chemistry Systems APO CAL (Apolipoprotein Calibrator) (2014-12-09)

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Agency
Health Canada — Medical Devices
Recall identifier
52963
Date of alert
2014-12-29
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: Beckman coulter has confirmed the Immage Immunochemistry Systems Apolipoprotein A-1 (APA) reagent (lot number M404171) contains an important product notification insert with incomplete information. The notification references only APA lot number M401225, but should reference APA lot numbers M401225 and newer. APA lot number m404171 calibrated with APO CAL lot number M305133 may produce inaccurate results (>6% low bias).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immage-immunochamistry-systems

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