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Recall Observatory FDA recall evidence

Device product

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

Z-0473-2023

November 21, 2022

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 91201
Status
Ongoing
Classification
Class II
Quantity
9,600 EA
Official record key
device-enforcement:Z-0473-2023

Official wording

Reason: Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

Code information: UDI: (10)2206461(17)221125(30)0100 Lot Number: 2206461 Exp. Date: 20221125. Box numbers 0002 through 0097. Boxes correlate to timestamps on the plates of 11:34 through 13:51. All other box numbers and plate stamps are unaffected and perform as intended. (Timestamps can be found on the bottom of the plate. The box number can be located on the carton label).

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.