PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 14, 2021 Initiated: March 17, 2021 #Z-1377-2021

Product 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

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

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
15550 EA
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
Location
Sparks, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Becton Dickinson & Co.. Units affected: 15550 EA.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1377-2021.