MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code:… — Class II medical device recall Z-1794-2026
Ongoing recall by Beckman Coulter, Inc., reported 2026-04-15. Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
| Recall number | Z-1794-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., West Sacramento, CA, United States |
| Recall initiated | 2025-09-08 |
| Classified | 2026-04-08 |
| Reported by FDA | 2026-04-15 |
| Countries outside the US | PL |
| Quantity | 3 boxes |
| UPC / GTIN / UDI-DI | 15099590720568 |
| Model numbers | C32368 |
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 for recall
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1794-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.