Product Wiki · Recalls · Health Canada — Medical Devices

Mach 4 Universal HRP Polymer Kit With DAB (2013-11-20) — recall 50984

Health Canada — Medical Devices · Canada · 2014-01-06 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50984
Date of alert
2014-01-06
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: The manufacturer, Biocare Medical, has recently advised of a performance issue with the Betazoid DAB buffer (Catalogue # DS900l, lot 081913) contained within the Mach 4 Universal HRP-Polymer detection kit (Catalogue # BRI4012l, lot 090913). This recall has been initiated due to the staining performance of the kit. The failure is evident when processing control slides as a complete absence of staining by the chromogen. The root cause of this failure is an incorrect buffer was packaged in the kit.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mach-4-universal-hrp-polymer-k

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