Recall Z-2306-2012 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Princeton Biomeditech Corp
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is
| Date | Aug 31, 2012 (initiated Mar 9, 2012) |
| Status | Terminated |
| Reason | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 370 (12 tests per kit) ;2800 kits (22 tests per kit) |
| Distribution | Nationwide Distribution-including the states of NJ, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083746 | BIOSIGN FLU A+B Princeton BioMeditech Corp., Nov 10, 2010 |