Recall Z-0473-2023 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Becton Dickinson & Co.
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
| Date | Dec 9, 2022 (initiated Nov 21, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | BD initiated the recall on November 21, 2022 via Urgent Medical Device Correction Letter. to Distributors and Risk Managers. Letter states reason for recall, health risk and action to take: Immediately inspect your inventory for the specific catalog and lot number listed above. Affected product includes box numbers 0002 through 0097. These boxes correlate to timestamps on the plates of 11:34 through 13:51. Timestamps can be found on the bottom of the plate. The box number can be located on the 2. Share and post this recall letter within your facility network and forward to any customers to who |
| Quantity | 9,600 EA |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.