VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a
FDA device recall Z-0482-2014 · posted 2013-12-11 · Terminated
Recall details
- Recalling firm
- Accumetrics Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOZ
- Quantity affected
- 69 units
- Distribution
- Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
- Date initiated
- 2013-11-14
- Date posted
- 2013-12-11
- Date terminated
- 2013-12-23
- 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 |