FDA Device Recall Z-0025-05: Becton Dickinson & Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0025-05.

Recall Res Number

Z-0025-05

Recalling Firm / Manufacturer

Becton Dickinson & Co.

FEI Number

1119779

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-09-29

Date Posted

2004-10-20

Date Terminated

2005-02-08

Product Code

JTS

Event Number

30184

Product Quantity

N/A

Product Description 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.

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

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

Code Information / Serial Numbers 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

Related Establishments / Registrations

Microbiologics, Inc. Registration: 1050138 View Registration
BECTON, DICKINSON & CO. Registration: 1119779 View Registration
E K INDUSTRIES, INC. Registration: 1419699 View Registration
MERIDIAN BIOSCIENCE, INC. Registration: 1524213 View Registration
ROCKY MOUNTAIN REAGENTS, INC. Registration: 1711690 View Registration
ELITechGroup Inc Registration: 1717966 View Registration
RICHARD-ALLAN SCIENTIFIC LLC Registration: 1831638 View Registration
REMEL, INC. Registration: 1924669 View Registration
BIOMERIEUX, INC. Registration: 1950204 View Registration
MEDICAL CHEMICAL CORPORATION Registration: 2013736 View Registration
HARDY DIAGNOSTICS Registration: 2022807 View Registration
CalibreScientific US, Inc. Registration: 2025606 View Registration
VENTANA MEDICAL SYSTEMS, INC. Registration: 2028492 View Registration
MICROBIOLOGICS, INC. Registration: 2150138 View Registration
JAMES ALEXANDER CORP. Registration: 2242239 View Registration
Ethos Biosciences, INC. Registration: 2247035 View Registration
POLYSCIENCES, INC. Registration: 2518071 View Registration
VOLUSOL Registration: 3002805583 View Registration
NEWCOMER SUPPLY INC Registration: 3008174888 View Registration
BIOGENEX LABORATORIES INC. Registration: 3008776165 View Registration
RAL DIAGNOSTICS Registration: 3009000266 View Registration
EMD MILLIPORE CORPORATION Registration: 3009432145 View Registration
Hardy Diagnostics Registration: 3009547954 View Registration
DAGATRONICS CORPORATION Registration: 3009596884 View Registration
AZER SCIENTIFIC, INC. Registration: 3009963993 View Registration
RR Donnelley Global Turnkey Solutions Registration: 3013160357 View Registration
CHAPTEC AMERICA Registration: 3017970519 View Registration
MDD OPTIONS, LLC Registration: 3040937533 View Registration
BIO-GRAM DIAGNOSTICS GMBH Registration: 3044854712 View Registration
MERCK KGAA Registration: 9610140 View Registration
BIOMERIEUX SA Registration: 9615754 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0025-05

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer