Product Wiki · Recalls · Health Canada — Medical Devices

Rota-strip Test Kit (2014-08-25) — recall 52402

Health Canada — Medical Devices · Canada · 2014-09-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52402
Date of alert
2014-09-22
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: The intensity of the rotavirus test line signals generated by the incriminated rota positive control could be judged too weak. As a consequence, one may erroneously conclude that the tested diagnostic kit quality is beyond the expectations and that weak positive signals could be missed with clinical samples.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/rota-strip-test-kit-2014-08-25

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