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Accumetrics Inc recalls VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The Veri
Recalled March 19, 2014 · FDA recall Z-1172-2014 · Accumetrics
Hazard
Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU. · FDA Class II
Units
576 units total (524 units in US)
Sold at
USA Nationwide Distribution
Description
Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.
Product
VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
Manufacturer(s)
Accumetrics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →