Accriva Diagnostics, Inc. is recalling 125 boxes (containing 3,125 tests) of the VerifyNow PRUTest Platelet Reactivity Test (REF 85225). These medical devices were incorrectly packaged and distributed before they had received the required premarket clearance from the FDA. You should stop using the affected test plates immediately and contact the manufacturer or your distributor to arrange for a return, replacement, or correction of the product.
The use of a diagnostic test that has not received FDA clearance means the device's accuracy and safety standards have not been officially verified, potentially leading to incorrect medical readings. No injuries or incidents have been reported in relation to this distribution error.
125 boxes (3,125 tests) total quantity affected.
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Sources: FDA iRES · Raw API Response
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