Recall Z-1378-2021 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Becton Dickinson & Co.
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221557
| Date | Mar 17, 2021 |
| Status | Terminated |
| Reason | Products show heavy growth of C. albicans after 24 hours of incubation due to misformulation (expected reaction is partial inhibition after 18-48 hours incubation) and reduce the identification of Neisseria contributing to a delay in time to definitive diagnosis or a delay in proper treatment |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Correction letter on 3/17/21 to customers and distributors via FedEx tracked letter. Letter states reason for recall, health risk and action to take: 1.Immediately inspect your inventory for the specific catalog and lot numbers listed above. Destroy all products subject to the recall following your institutions process for destruction. 2.Share this recall notification with all users within your facility network to ensure they are also aware of this recall. 3.Complete the attached Customer Response Form and return to the BD contact noted on the form whether or |
| Quantity | 33660 EA |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K770287 | MARTIN-LEWIS AGAR MEDIUM Gibco Laboratories Life Technologies, Inc., Feb 18, 1977 |