Product Wiki · Recalls · Health Canada — Medical Devices

Aeroset System – Phenobarbital Reagent — recall 49280

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

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Agency
Health Canada — Medical Devices
Recall identifier
49280
Date of alert
2012-12-24
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: Abbott Diagnostics is recalling clinical chemistry phenobarbital reagent lots 62299un12 and 85773un12 due to imprecision issues which increase with the age of the reagent lot. The imprecision of the phenobarbital assay is less than or equal to 7% total cv%, however, internal testing confirmed cvs up to approximately 12% for in-date reagent lots over five months old. Although lot 52803un12 is now expired, it exhibited similar imprecision issues. As a precaution, future replacement lots will have reduced dating until root cause is identified and preventive measures are implemented.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/aeroset-system-phenobarbital-r

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