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Becton Dickinson & Co. recalls BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swa
Recalled June 12, 2024 · FDA recall Z-2023-2024 · Becton Dickinson &
Hazard
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. · FDA Class II
Units
2,061 kits
Sold at
Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Description
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
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.
Manufacturer(s)
Becton Dickinson & Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →