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Recall Observatory FDA recall evidence

Device product

BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.

Z-1801-2013

June 06, 2013

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 65614
Status
Terminated
Classification
Class II
Quantity
106 cartons
Official record key
device-enforcement:Z-1801-2013

Official wording

Reason: Microbiological identification media may exhibit reduced levels of Vancomycin.

Code information: Lot 3080366 Exp 5/31/13 Lot 3071134 Exp 5/28/13 Lot 3081061 Exp 6/4/13

Distribution pattern: Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Microbiological identification media may exhibit reduced levels of Vancomycin.