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Terminated

Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** Used for the identification of Shigella species by the slide agglutination test

FDA Recall Z-1528-2008 · Posted 2008-08-16

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeGNB
Date Initiated2007-11-30
Date Terminated2008-11-12
Product Quantity643 (recall total) vials

Reason for Recall

In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.

Firm Action

The recalling firm notified distributors by faxed letter flagged as "Urgent Product Recall" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an "Urgent Product Recall" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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