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Terminated

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.

FDA Recall Z-1172-2014 · Posted 2014-03-11

Recalling FirmAccumetrics Inc
Recall StatusTerminated
Product CodeJOZ
Date Initiated2014-02-13
Date Terminated2014-08-23
Product Quantity576 units total (524 units in US)

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.

Firm Action

Accumetrics sent an Urgent Medical Device Recall letter dated February 13, 2014 to all affected customers. The recall letter informs the customers of the problems identified and the actions to be taken. Cusotomers are instructed to complete the attached Customer Account Tracking Form and return it within 10 days by fax, email or mail. Customers with questions are instructed call Accumetrics Customer Support at (800) 643-1640 option 2 or email at [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013596MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)Accumetrics, Inc. · 2002-05-16K011337ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)Accumetrics, Inc. · 2001-10-16K992531ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEMAccumetrics, Inc. · 1999-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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