RecallDepth

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.

This recall has been terminated (originally issued January 14, 2015).

Company
Becton Dickinson & Co. Bd Diagnostic Systems
Recall Initiated
June 6, 2014
Posted
January 14, 2015
Terminated
August 12, 2016
Recall Number
Z-0976-2015
Quantity
775 cases
Firm Location
Sparks, MD
Official Source
View on FDA website ↗

Reason for Recall

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.

Distribution

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

Lot / Code Info

Catalogue # 221263 with Lot #4099228

Root Cause

Material/Component Contamination

Action Taken

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.

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