FDA recall Z-1377-2021

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-03-17

Report date

2021-04-14

Termination date

2022-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1377-2021