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U.S. Department of Health and Human Services

Class 3 Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731,

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  Class 3 Device Recall Difco Salmonella 0 Group A Antigen, catalog 240731, see related information
Date Initiated by Firm May 19, 2010
Date Posted July 15, 2010
Recall Status1 Terminated 3 on July 21, 2010
Recall Number Z-2025-2010
Recall Event ID 55867
Product Classification Antigens, febrile, slide and tube, all groups, salmonella spp - Product Code GNC
Product Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson and Company, Sparks, MD 21152***
Code Information Lot 9126057, Exp May 04, 2012
Recalling Firm/
Becton Dickinson & Co.
BD Diagnostic Systems
7 Loveton Circle
Sparks MD 21152-0999
For Additional Information Contact Kim Cartier
Manufacturer Reason
for Recall
In vitro diagnostic reagent to aid in the diagnosis of Salmonellosis may exhibit decreased or no reactivity. If proper controls are run with the lot in question, it would become apparent that the antigen is non reactive and patient specimen results should not be reported. If control testing is not performed a salmonella-infected patient could go undiagnosed, with possible adverse effects.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The recalling firm notified customers by fax and e-mail on 05/19/10. The notification advised that the referenced lot number of Salmonella 0 Group A Antigen may exhibit decreased or no reactivity when testing the patient's serum directly for homologous antibodies by either a slide or tube agglutination test to aid in the diagnosis of Salmonellosis. The recalling firm also advised that they would issue replacements for the referenced lot number under Catalog number 240731, which would not be available until approximately July 15, 2010. Consignees were requested to return enclosed response form. Customers with questions about replacements should contact BD customer service at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.
Quantity in Commerce 93 units
Distribution Product was sold to distributors nationwide and to affiliates in Belgium and Korea.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.