Z-2023-2024 Class II Ongoing
FDA device recall Z-2023-2024 was initiated by Becton Dickinson & Co. on May 7, 2024 and is designated Class II. Reason for recall: Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. The recall status is ongoing. Affected quantity: 2,061 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2024
- Initiation Date
- May 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,061 kits
Product 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 for Recall
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: AU, BR, BE, CA, CO, & JP.
Code Information
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).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2023-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026