Recall archive / FDA device enforcement
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan D... — FDA record Z-1794-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 8, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 3 boxes
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1794-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Poland.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 15, 2026
- Recall initiation date
- Sep 8, 2025
- Center classification date
- Apr 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.