Medical Device
Manufacturing
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Z-1787-2010

Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson...

Becton Dickinson & Co / initiated 2009-12-09 / Terminated

Becton Dickinson & Co. began a recall of Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD... on . The reason FDA records is "Diagnostic test reagents may not meet quality control specifications". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1787-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles, labeled in part ***Becton Dickinson Microbiology Systems, Becton Dickinson, Sparks, MD 21152***
Product code
JSI Culture Media, Selective And Differential
Reason for recall
Diagnostic test reagents may not meet quality control specifications.
FDA root cause
Other
Action
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.
Quantity in commerce
209 bottles
Distribution
The product was sold to distributors in the US and to affiliates internationally. A complete list is not currently available.
Product codes and lots
Batch No. Exp. Date 9131598 12/13/2013 9055843 12/13/2013