Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a component in

FDA device recall Z-1527-2008 · posted 2008-08-16 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

GNB

Quantity affected

643 (recall total) vials

Distribution

Worldwide Distribution

Date initiated

2007-11-30

Date posted

2008-08-16

Date terminated

2008-11-12

Location

Sparks, MD