Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercar
FDA device recall Z-0373-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Diagnostic test kit may exhibit false positive results.
- Action taken
- The recalling firm notified consignees by fax, e-mail and letters 12/15/03. The letter advised of the false positive test results and requested end users to discontinue use and discard remaining packages for replacement. Consignees were requested to return response form.
- Root cause
- Other
- Status
- Terminated
- Product code
- GQG
- Quantity affected
- 600 kits
- Distribution
- Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
- Date initiated
- 2003-12-15
- Date posted
- 2004-07-20
- Date terminated
- 2004-06-21
- Location
- Sparks, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD DIRECTIGEN EZ RSV KIT (K022133) | Becton, Dickinson & CO | 2002-12-10 |