FDA Device recall Z-2023-2024
BD SARS-CoV-2 Reagents for BD MAX" Systems
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of BD SARS-CoV-2 Reagents for BD MAX" Systems by Becton Dickinson And, citing assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2023-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-07 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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.
Reason
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
Identifiers
| code_info | Catalog No. 445003-01; UDI-DI: (01) 60382904450030 (17) 240803 (10) 3291356 (20) 01 (30) 1, (01) 60382904450030 (17)…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2023-2024%22
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