Product Wiki · Recalls · Health Canada — Medical Devices

IRISPEC CA/CB/CC (2016-04-11) — recall 55067

Health Canada — Medical Devices · Canada · 2016-04-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55067
Date of alert
2016-04-22
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: Iris International has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the IRIspec CA bilirubin control material. The IRIspec CA control may fail for the bilirubin analyte. The laboratory will be unable to process patient samples until QC passes. Not all bottles within a specific lot may be affected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/irispec-cacbcc-2016-04-11

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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