Recall Z-0778-04 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Binax, Inc.
NOW RSV Test Item Number 430-430, Kit Number 430-00R
| Date | Jul 20, 2004 (initiated Feb 18, 2004) |
| Status | Terminated |
| Reason | Pouch integrity compromised |
| Root cause | Other |
| Action | Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter. |
| Quantity | 667 kits |
| Distribution | KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India |
| 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 |