Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914
FDA device recall Z-2307-2012 · posted 2012-08-31 · Terminated
Recall details
- Recalling firm
- Princeton Biomeditech Corp
- Reason for recall
- There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- Action taken
- OraSure Technologies, Inc. sent an "IMPORTANT NOTICE FOR ORASURE QUICKFLU RAPID FLU A + B TEST" letter dated March 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 610-882-1820 for questions concerning this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GNX
- Quantity affected
- 103 kits (22 tests per kit)
- Distribution
- Nationwide Distribution-including the states of NJ, NY, and PA.
- Date initiated
- 2012-03-09
- Date posted
- 2012-08-31
- Date terminated
- 2014-10-14
- Location
- Monmouth Junction, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSIGN FLU A+B (K083746) | Princeton BioMeditech Corp. | 2010-11-10 |