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Terminated

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.

FDA Recall Z-0025-05 · Posted 2004-10-20

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJTS
Date Initiated2004-09-29
Date Terminated2005-02-08

Reason for Recall

Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was sold to distributors and end-users nationwide and to the firm''s international affiliates.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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