FDA Recall Terminated

Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.

Recall: Z-0976-2015 · Initiated June 6, 2014

Recall

Recall Number
Z-0976-2015
Event Number
69091
Firm
Becton Dickinson & Co. BD Diagnostic Systems
FEI Number
1119779
Product Code
JSG
Status
Terminated
Root Cause
Material/Component Contamination
Initiated
June 6, 2014
Posted
January 14, 2015
Terminated
August 12, 2016
Address
7 Loveton Circle, Sparks, MD, 21152-0999

Description

Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.

Reason

A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

Action

BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000.

Distribution

Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.

Quantity

775 cases