Device product

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

Z-1377-2021

March 17, 2021

Class II

Product summary

Firm: Becton Dickinson & Co.
Event: Event 87546
Status: Terminated
Classification: Class II
Quantity: 15550 EA
Official record key: device-enforcement:Z-1377-2021

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 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

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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