FDA Recall Terminated

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

Recall: Z-1787-2010 · Initiated December 9, 2009

Recall

Recall Number
Z-1787-2010
Event Number
55697
Firm
Becton Dickinson & Co.
FEI Number
1119779
Product Code
JSI
Status
Terminated
Root Cause
Other
Initiated
December 9, 2009
Posted
June 11, 2010
Terminated
June 14, 2010
Address
7 Loveton Cir, Sparks, MD, 21152-9212

Description

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

Reason

Diagnostic test reagents may not meet quality control specifications.

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.

Distribution

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

Quantity

209 bottles