FDA Device recall Z-1794-2026
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC…
- FDA Device
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC… by Beckman Coulter, citing due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1794-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-08 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
Product
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Reason
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Identifiers
| code_info | Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1794-2026%22
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