Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog #
FDA device recall Z-0025-05 · posted 2004-10-20 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JTS
- Distribution
- Product was sold to distributors and end-users nationwide and to the firm''s international affiliates.
- Date initiated
- 2004-09-29
- Date posted
- 2004-10-20
- Date terminated
- 2005-02-08
- Location
- Sparks, MD
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