Becton Dickinson & Co. Recall 87546
Description: BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558
Becton Dickinson & Co. Recall 87546 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1377-2021 |
| Event ID | 87546 |
| Event Description | BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea. |
| Quantity | 15550 EA |
| Recall 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 |
| Device Classification | 20210414 |
| Device Code Info | Lot Numbers: 0317559 Exp. Date 2021-MAR-11; 0345695 Exp. Date 2021-APR-06 UDI: 01)30382902215586 (10)0317559(17)031121 (30)0100 (01)30382902215586 (10)0345695(17)040621 (30)0100 |
| Center Classification Date | 20210408 |
| Recall Initiation Date | 20210317 |
| Recalling Firm | Becton Dickinson & Co. |
| Initial Notification | Letter |
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