Recall Z-0025-05 ยท JTS Stains, Microbiologic
Becton Dickinson & Co.
Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.
| Date | Oct 20, 2004 (initiated Sep 29, 2004) |
| Status | Terminated |
| Reason | Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples. |
| Root cause | Other |
| Action | The recalling firm notified distributors and direct accounts by fax, certified letter, and e-mail on 9/29/04. The notifications advised that staining characteristics may not be appropriate, and that product should be discarded for replacement. Distributors were additionally requested to provide a consignee list for direct notification by BD. Consignees were requested to return response form. |
| Distribution | Product was sold to distributors and end-users nationwide and to the firm''s international affiliates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.