NOW RSV Test Item Number 430-430, Kit Number 430-00R
FDA device recall Z-0778-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Binax, Inc.
- Reason for recall
- Pouch integrity compromised
- Action taken
- Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- GQG
- Quantity affected
- 667 kits
- Distribution
- KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
- Date initiated
- 2004-02-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-09
- Location
- Portland, ME
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166) | Binax, Inc. | 2003-10-21 |