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Medical Devices / Postmarket Safety

Ireland Regulator Releases Safety Notice for Rapid Tests

July 11, 2016

Ireland’s Health Products Regulatory Authority is temporarily banning use of Biotest’s RightSign rapid tests for HIV, HCV and HBV distributed in the Irish market.

In a Priority 2 warning, HPRA warns providers that the tests manufactured by Hangzhou Biotest Biotech in Hangzhou, China, were being discontinued until further notice. The agency requested that users report any incidents and follow-up with patients tested with any RightSign product.

 In a letter dated June 16, Biotest issued a field safety notice after being notified by France’s ANSM cautioning on nonconformities. The agency noted that it hadn’t received any false results, but it was taking the action to avoid potential risk.

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