Recall Z-0373-04 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Becton Dickinson & Co.
Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
| Date | Jul 20, 2004 (initiated Dec 15, 2003) |
| Status | Terminated |
| Reason | Diagnostic test kit may exhibit false positive results. |
| Root cause | Other |
| Action | 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. |
| Quantity | 600 kits |
| Distribution | Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022133 | BD DIRECTIGEN EZ RSV KIT Becton, Dickinson & CO, Dec 10, 2002 |