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

FDA device recall Z-1787-2010 · posted 2010-06-11 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Diagnostic test reagents may not meet quality control specifications.

Action taken

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

Status

Terminated

Product code

JSI

Quantity affected

209 bottles

Distribution

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

Date initiated

2009-12-09

Date posted

2010-06-11

Date terminated

2010-06-14

Location

Sparks, MD