—#35322

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.

FDA product code: JTS — Stains, Microbiologic
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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

Timeline

Recall initiated: 2004-09-29
Posted by FDA: 2004-10-20
Terminated: 2005-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.