Becton Dickinson & Co. Recall 91201
Description: BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Becton Dickinson & Co. Recall 91201 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0473-2023 |
| Event ID | 91201 |
| Event Description | BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines. |
| Quantity | 9,600 EA |
| Recall 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. |
| Device Classification | 20221221 |
| Device Code Info | 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). |
| Center Classification Date | 20221209 |
| Recall Initiation Date | 20221121 |
| Recalling Firm | Becton Dickinson & Co. |
| Initial Notification | Letter |
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