Z-0482-2014Class II

VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow...

Name: Z-0482-2014 VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow...
Creator: Accumetrics Inc
Published: 2013-11-14
License: https://open.fda.gov/license/

Accumetrics, Inc. / initiated 2013-11-14 / Terminated

FDA source

Accumetrics Inc began a recall of 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... on 2013-11-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0482-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-14
Posted: 2013-12-11
Terminated: 2013-12-23
Recalling firm: Accumetrics, Inc.
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.
Product code: JOZ System, Automated Platelet Aggregation
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.
FDA root cause: Other
Action: Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test. The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at [email protected]. Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible. For questions regarding this recall call 858-643-1600.
Quantity in commerce: 69 units
Distribution: Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
Product codes and lots: Lot No. WC0181H, WC0181J, WC0181K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0482-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0482-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-11

Product code JOZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)