FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2023-2024
·
Reported June 12, 2024
Enforcement
- Recall Number
- Z-2023-2024
- Event ID
- 94599
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 12, 2024
- Initiation Date
- May 7, 2024
- Classification Date
- June 5, 2024
- Address
- 7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States
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.
Reason
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Code Info
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
Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Quantity
2,061 kits