Product Wiki · Recalls · Health Canada — Medical Devices

AmniSure ROM Test Strips (2018-05-18) — recall 60998

Health Canada — Medical Devices · Canada · 2018-06-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
60998
Date of alert
2018-06-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Health products
Product type
Medical devices
Reported risk: Qiagen has determined that the AmniSure ROM Test Strips have the potential for not exhibiting a control line. A test strip that has no control line is an invalid test and a result cannot be interpreted.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/amnisure-rom-test-strips-2018-

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