—#91593

Product

Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD 21152***

FDA product code: JSI — Culture Media, Selective And Differential
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Batch No. Exp. Date 9131598 12/13/2013 9055843 12/13/2013

Why it was recalled

Diagnostic test reagents may not meet quality control specifications.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm notified distributors by letter flagged as "Urgent Product Recall" on 12/09/09. The letter instructed distributors to discontinue distribution and discard product. Distributors were asked to provide customer lists and the recaller subsequently notified the end users to discontinue and discard identified lots for replacement. Customers were asked to return a response form. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: The product was sold to distributors in the US and to affiliates internationally. A complete list is not currently available.

Timeline

Recall initiated: 2009-12-09
Posted by FDA: 2010-06-11
Terminated: 2010-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91593. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.