ClearanceBrief
Recall Z-1787-2010 ยท JSI Culture Media, Selective And Differential

Becton Dickinson & Co.

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

DateJun 11, 2010 (initiated Dec 9, 2009)
StatusTerminated
ReasonDiagnostic test reagents may not meet quality control specifications.
Root causeOther
ActionThe 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 1-800-63
Quantity209 bottles
DistributionThe product was sold to distributors in the US and to affiliates internationally. A complete list is not currently available.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.