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Terminated

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

FDA Recall Z-1787-2010 · Posted 2010-06-11

Recall StatusTerminated
Product CodeJSI
Date Initiated2009-12-09
Date Terminated2010-06-14
Product Quantity209 bottles

Reason for Recall

Diagnostic test reagents may not meet quality control specifications.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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