Becton Dickinson & Co.: Medical Device Recall in 2024 - (Recall #: Z-2023-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 7, 2024

Date Posted: June 12, 2024

Recall Number: Z-2023-2024

Event ID: 94599

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2,061 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated