Recall Z-0824-2007 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Binax, Inc. dba IMPD
BinaxNOW RSV 10 Test Kit Part Number : 430-100, 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 | 2851 kits |
| Distribution | Nationwide and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032166 | BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 Binax, Inc., Oct 21, 2003 |