—#68191

Product

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 product code: GNB — Antisera, All Types, Shigella Spp.
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot 6009070 Exp November 03, 2011

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 #68191. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.