VerifyNow IIb/IIIa Test — Class II medical device recall Z-1172-2014
Terminated recall by Accumetrics Inc, reported 2014-03-19, distributed nationwide. Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous lo
| Recall number | Z-1172-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accumetrics Inc, San Diego, CA, United States |
| Recall initiated | 2014-02-13 |
| Classified | 2014-03-10 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2014-08-23 |
| Distributed | Nationwide (US) |
| Serial numbers | WC0180A, WC0180B, WC0180C, WC0180D, WC0180E, WC0180F, WC0181A, WC0181B, WC0181C, WC0181D, WC0181E, WC0181F, WC0181G, WC0181H, WC0181J, WC0181K, WC0182A, WC0182B, WC0182C, WC0182D, WC0182E, WC0182F, WC0182G |
| Model numbers | 10-TEST, 25-TEST, 85011, 85310 |
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.