Product Wiki · Recalls · Health Canada — Medical Devices

Salmonella Agglutinating Serum O poly A-S (2016-06-10) — recall 55135

Health Canada — Medical Devices · Canada · 2016-06-24 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55135
Date of alert
2016-06-24
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 overall performance of the antisera has deteriorated and this is more marked in some factors than others. The product was deemed not fit for purpose as it had deteriorated since being put on the market. It was still agglutinating with most salmonella cultures tested against, but was slower against some of the higher somatics, as it is not detecting within one minute which is stated in the instructions for use.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/salmonella-agglutinating-serum

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