Z-1378-2021 Class II Terminated
FDA device recall Z-1378-2021 was initiated by Becton Dickinson & Co. on March 17, 2021 and is designated Class II. 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 Ne… The recall status is terminated (terminated August 5, 2022). Affected quantity: 33660 EA.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 17, 2021
- Termination Date
- August 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33660 EA
Product Description
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
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 Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Korea.
Code Information
Lot Number: 0317558, Exp. Date 2021-MAR-11 UDI: (01)30382902215579 (10)0317558(17)031121 (30)0020