Recalls / —
—#88347
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.
- FDA product code
- LIA — Antigens, All Groups, Shigella Spp.
- Device class
- Class 2
- Medical specialty
- Microbiology
- Affected lot / code info
- Lot Number: 8032036, exp 7/23/2010 and Lot Number: 9110319, exp 11/17/2011.
Why it was recalled
In vitro diagnostic test reagent may exhibit decreased reactivity.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Co.
- Address
- 7 Loveton Cir, Sparks, Maryland 21152-9212
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2010-01-25
- Posted by FDA
- 2010-03-16
- Terminated
- 2010-05-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #88347. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.