Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials, labeled in part ***Becton, Dickinson

FDA device recall Z-2025-2010 · posted 2010-07-15 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GNC

Quantity affected

93 units

Distribution

Product was sold to distributors nationwide and to affiliates in Belgium and Korea.

Date initiated

2010-05-19

Date posted

2010-07-15

Date terminated

2010-07-21

Location

Sparks, MD