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Recall Observatory FDA recall evidence

Device product

CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.

Z-0975-2015

June 06, 2014

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 69091
Status
Terminated
Classification
Class II
Quantity
1,530 cases (100 plates/case)
Official record key
device-enforcement:Z-0975-2015

Official wording

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.

Code information: Catalogue # 221734 with Lot #4077423

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contamination of Listeria monocytogenes