Class II

Medical Device Recall: 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.

Becton Dickinson & Co. · May 7, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

2,061 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2023-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.