Recall Z-1172-2014 ยท JOZ System, Automated Platelet Aggregation
Accumetrics Inc
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
| Date | Mar 11, 2014 (initiated Feb 13, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 support@accumetrics.com. |
| Quantity | 576 units total (524 units in US) |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) Accumetrics, Inc., Oct 16, 2001 |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) Accumetrics, Inc., May 16, 2002 |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM Accumetrics, Inc., Dec 20, 1999 |