—#67181

Product

Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in the Difco(tm) "Shigella Grouping Antiserum Set", Cat. 241108, Lot 6073806). Vials are labeled in part ***S. flexneri Serotypes 1-6***Becton, Dickinson and Company Sparks, MD 21152*** Used for the identification of Shigella species by the slide agglutination test.

FDA product code: GNB — Antisera, All Types, Shigella Spp.
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot 5059542 Exp March 30, 2008 Lot 6023471 Exp March 30, 2008 Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2007-11-30
Posted by FDA: 2008-08-16
Terminated: 2008-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.