Z-0025-05

Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles...

Name: Z-0025-05 Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles...
Creator: Becton Dickinson & Co.
Published: 2004-09-29
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2004-09-29 / Terminated

FDA source

Becton Dickinson & Co. began a recall of 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 on 2004-09-29. The reason FDA records is "Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0025-05
Status: Terminated
Initiated: 2004-09-29
Posted: 2004-10-20
Terminated: 2005-02-08
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: JTS Stains, Microbiologic
Reason for recall: Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
FDA 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.
Product codes and lots: Lots 4223220, Exp 5/28/05 4226886, Exp 5/28/05 4233156, Exp 5/28/05 4237134, Exp 6/30/05 4226882, Exp 5/28/05 4237144, Exp 6/30/05

Product code JTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)