FDAFDA · Food and drugs·Recall number Z-2023-2024
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.
Published June 12, 2024 · Recall initiated: May 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
- Lot
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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