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Terminated

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.

FDA Recall Z-1149-2010 · Posted 2010-03-16

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLIA
Date Initiated2010-01-25
Date Terminated2010-05-21
Product Quantity1096 units

Reason for Recall

In vitro diagnostic test reagent may exhibit decreased reactivity.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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