TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is use

FDA device recall Z-0974-2015 · posted 2015-01-14 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

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.

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

JSI

Quantity affected

7,617 cases (100 plates/case)

Distribution

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

Date initiated

2014-06-06

Date posted

2015-01-14

Date terminated

2016-08-12

Location

Sparks, MD