Becton Dickinson & Co.: 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: 22

Is my product affected?

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

• UPC 30382902215586

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Co. is recalling BD BBL Martin-Lewis Agar (Catalog Number 22) used to isolate disease-causing Neisseria bacteria from clinical specimens. The products were misformulated and show heavy growth of C. albicans fungus after 24 hours of incubation instead of the expected partial inhibition. This defect reduces the ability to identify Neisseria, which can delay diagnosis or delay proper treatment of infections.

The recall affects 15,550 units distributed worldwide in the United States, Canada, and Korea. Two lot numbers are affected: Lot 0317559 with an expiration date of March 11, 2021, and Lot 0345695 with an expiration date of April 6, 2021. The source record does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. Quantity: 15550 EA Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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