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.
Biotest has issued a recall of the valid batches from the European market. The distributor recommends halting sales of the specified products and disposing of any unused products. Affected products include: 10 lots of the HBsAg Rapid Test Cassette, eight lots of the HCV Rapid Test Cassette, and eight lots of the HIV 1.2.0 Rapid Test Cassette.
Read HPRA’s safety notice here: www.fdanews.com/06-30-16-HPRASafetyNotice.pdf. Biotest’s field safety notice can be found here: www.fdanews.com/06-30-16-BiotestFieldSafetyNotice.pdf. — Joya Patel