Z-1149-2010

BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled...

Name: Z-1149-2010 BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled...
Creator: Becton Dickinson & Co.
Published: 2010-01-25
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-01-25 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton... on 2010-01-25. The reason FDA records is "In vitro diagnostic test reagent may exhibit decreased reactivity". 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-1149-2010
Status: Terminated
Initiated: 2010-01-25
Posted: 2010-03-16
Terminated: 2010-05-21
Recalling firm: Becton Dickinson & Co
Product: BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog #24103, and labeled in part. Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA. Used to confirm the identification of isolates that are morphologically and biochemically identified as Shigella species.
Product code: LIA Antigens, All Groups, Shigella Spp.
Reason for recall: In vitro diagnostic test reagent may exhibit decreased reactivity.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD Diagnostic Systems issued an "Urgent Product Recall" notification dated January 2010. Consignees were advised to discontinue use of the affected product and discard for replacement or credit. For further information, contact BD Diagnostic Systems, Customer Service at 1-800-675-0908.
Quantity in commerce: 1096 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Number: 8032036, exp 7/23/2010 and Lot Number: 9110319, exp 11/17/2011.

Product code LIA

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)