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Recall Observatory FDA recall evidence

Device product

BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)

Z-0528-2019

October 22, 2018

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 81572
Status
Terminated
Classification
Class II
Quantity
54,300 plates
Official record key
device-enforcement:Z-0528-2019

Official wording

Reason: a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.

Code information: UDI - (01)10382902212611(17)181130 (10)8221508 Lot No.: 8221508 Expiration Date: 2018-11-30

Distribution pattern: US Nationwide distribution in the states of AL, AR, AZ, CA, CT, FL, GA, HI, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, PA, RI, TX, VA, VT, WA, WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    a portion of a single lot was not manufactured in accordance with the internal formulation resulting in inhibited growth of Gram negative organisms.