Becton Dickinson & Co.: 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.

Hazard

Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

Details from the source

Reason for recall: Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. Distribution: Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP. Quantity: 2,061 kits Lot/code info: 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).

UPC codes

60382904450030

Source

Official record: FDA (Device enforcement) ↗

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