Atlas FDA

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

FDA device recall Z-1149-2010 · posted 2010-03-16 · Terminated

Recall details

Recalling firm
Becton Dickinson & Co.
Reason for recall
In vitro diagnostic test reagent may exhibit decreased reactivity.
Action taken
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
Status
Terminated
Product code
LIA
Quantity affected
1096 units
Distribution
Nationwide Distribution
Date initiated
2010-01-25
Date posted
2010-03-16
Date terminated
2010-05-21
Location
Sparks, MD

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