FDAFDA · Food and drugs·Recall number Z-0473-2023
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Published December 21, 2022 · Recall initiated: November 21, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
- Lot
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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