Product Wiki · Recalls · Health Canada — Medical Devices

ZYM B REAGENT (2015-12-23) — recall 54772

Health Canada — Medical Devices · Canada · 2016-02-08 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54772
Date of alert
2016-02-08
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: Based on discrepant results (false negative results) reported from the field, bioMérieux initiated a complaint investigation. A loss of performance due to light exposure after 3 months of shelf life for API ZYM B, which lead to false negative results on some API strips using the ZYM B (API 20 Strep-20600, API Coryne-20900, API Staph-20500, API ZYM-25200, API NH-10400, API Listeria-10300).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/zym-b-reagent-2015-12-23

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