Recall Z-0482-2014
Accumetrics Inc · initiated November 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot No. WC0181H, WC0181J, WC0181K
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-determined cause: Other
Action taken
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 support@accumetrics.com. 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.
Details
- Recall number
- Z-0482-2014
- Initiated
- November 14, 2013
- Posted by FDA
- December 11, 2013
- Terminated
- December 23, 2013
- Product code
- JOZ – System, Automated Platelet Aggregation
- Quantity
- 69 units
- Distribution
- Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
- Recalling firm
- Accumetrics Inc, San Diego, CA