Device product
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
Z-1378-2021
Product summary
- Event
- Event 87546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33660 EA
- Official record key
device-enforcement:Z-1378-2021
Official wording
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
Code information: Lot Number: 0317558, Exp. Date 2021-MAR-11 UDI: (01)30382902215579 (10)0317558(17)031121 (30)0020
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
Derived failure modes
-
Unknown
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