VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow
FDA device recall Z-1172-2014 · posted 2014-03-11 · Terminated
Recall details
- Recalling firm
- Accumetrics Inc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JOZ
- Quantity affected
- 576 units total (524 units in US)
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2014-02-13
- Date posted
- 2014-03-11
- Date terminated
- 2014-08-23
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) (K013596) | Accumetrics, Inc. | 2002-05-16 |
| ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) (K011337) | Accumetrics, Inc. | 2001-10-16 |
| ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM (K992531) | Accumetrics, Inc. | 1999-12-20 |