FDA recall Z-2023-2024

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-05-07

Report date

2024-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sparks, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2023-2024