Z-0473-2023 Class II Ongoing
FDA device recall Z-0473-2023 was initiated by Becton Dickinson & Co. on Nov 21, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 9,600 EA.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Nov 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,600 EA
Product Description
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
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).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0473-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026