Accumetrics Inc: Medical Device Recall in 2013 - (Recall #: Z-0482-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 14, 2013

Date Posted: December 18, 2013

Recall Number: Z-0482-2014

Event ID: 66834

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.

Status: Terminated

Product Quantity: 69 units

Code Information:

Lot No. WC0181H, WC0181J, WC0181K

Distribution Pattern:

Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.

Voluntary or Mandated:

Voluntary: Firm initiated