Z-0473-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- November 21, 2022
- Termination Date
- N/A
- 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).