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
Check against the official notice below — it lists the full affected range.
Becton Dickinson & Co. is recalling BD BBL Martin-Lewis Agar (Catalog Number 22155) because the product is misformulated. The affected agar shows heavy growth of C. albicans after 24 hours of incubation instead of the expected partial inhibition after 18-48 hours. This misformulation reduces the identification of Neisseria bacteria, which can delay diagnosis or delay proper treatment. The recall affects 33,660 units of lot number 0317558 with an expiration date of March 11, 2021, distributed worldwide in the US, Canada, and Korea.
The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 33660 EA Lot/code info: Lot Number: 0317558, Exp. Date 2021-MAR-11 UDI: (01)30382902215579 (10)0317558(17)031121 (30)0020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.