Device product
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Z-2023-2024
Product summary
- Event
- Event 94599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,061 kits
- Official record key
device-enforcement:Z-2023-2024
Official wording
Reason: Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Code information: Catalog No. 445003-01; UDI-DI: (01) 60382904450030 (17) 240803 (10) 3291356 (20) 01 (30) 1, (01) 60382904450030 (17) 241119 (10) 3291358 (20) 01 (30) 1, (01) 60382904450030 (17) 241217 (10) 3326001 (20) 01 (30) 1; Lot No. 3291356 (Exp. 8/3/24), 3291358 (Exp. 11/19/24), 3326001 (Exp. 12/17/24).
Distribution pattern: Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Derived failure modes
-
Unknown
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.