VerifyNow IIb/IIIa Test — Class II medical device recall Z-0482-2014
Terminated recall by Accumetrics Inc, reported 2013-12-18, distributed nationwide. Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amou
| Recall number | Z-0482-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accumetrics Inc, San Diego, CA, United States |
| Recall initiated | 2013-11-14 |
| Classified | 2013-12-11 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2013-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 69 units |
| Lot numbers | WC0181H, WC0181J, WC0181K |
| Model numbers | 85310 |
Product
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. 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 lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
Reason for recall
Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
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.