CLASS II Device recall · Reported 18 Dec 2013 · FDA Enforcement Report
VerifyNow IIb/IIIa Test, 10-Test Kit recalled by Accumetrics
Accumetrics is recalling VerifyNow IIb/IIIa Test, 10-Test Kit, distributed nationwide in the US. The recall was initiated on 14 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0482-2014
- FDA event ID
- 66834
- Recalling firm
- Accumetrics, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2013
- FDA classified
- 11 Dec 2013
- Reported
- 18 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Nov 2013 | Recall initiated by company | |
| 11 Dec 2013 | Classified by FDA | +27 days |
| 18 Dec 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
Nationwide ArkansasArizonaConnecticutDistrict of ColumbiaIndianaNew JerseyNew MexicoNew YorkPennsylvaniaTexas
Questions about this recall
Is VerifyNow IIb/IIIa Test, 10-Test Kit recalled?
Yes. Accumetrics recalled VerifyNow IIb/IIIa Test, 10-Test Kit on 14 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0482-2014.
Why was it recalled?
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.
Which lots are affected?
Lot No. WC0181H, WC0181J, WC0181K
Where was it sold?
Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Accumetrics
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|---|---|---|---|---|---|
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