Recall Z-0822-2007 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Binax, Inc. dba IMPD
BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper
| Date | May 23, 2007 (initiated Mar 28, 2007) |
| Status | Terminated |
| Reason | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| Root cause | Other |
| Action | Inverness Medical issued recall notification by letter on 3/28/07. Customers are instructed to discard the NP swabs provided in the kits. The firm will replace the NP swabs. In the meantime customers are to use the tests with nasal wash/aspirate samples (influenza) or nasal wash samples (RSV). Response letters are to be signed by customers and returned to Inverness Medical. |
| Quantity | 2688 kits |
| Distribution | Nationwide and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062109 | BINAXNOW INFLUENZA A & B TEST Binax, Inc., Nov 9, 2006 |