Z-1527-2008

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

Name: Z-1527-2008 Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually sold or packed as a...
Creator: Becton Dickinson & Co.
Published: 2007-11-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2007-11-30 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of 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... on 2007-11-30. The reason FDA records is "In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1527-2008
Status: Terminated
Initiated: 2007-11-30
Posted: 2008-08-16
Terminated: 2008-11-12
Recalling firm: Becton Dickinson & Co
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.
Product code: GNB Antisera, All Types, Shigella Spp.
Reason for recall: In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 643 (recall total) vials
Distribution: Worldwide Distribution
Product codes and lots: Lot 5059542 Exp March 30, 2008 Lot 6023471 Exp March 30, 2008 Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010

Product code GNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)