BBL Chocolate II Agar- IVD for the isolation and recall
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Why was BBL Chocolate II Agar- IVD for the isolation and recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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).
- Product
- BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 9,600 EA
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.
- Recall date
- December 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)