Device 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.
Z-1794-2026
Product summary
- Event
- Event 98562
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 boxes
- Official record key
device-enforcement:Z-1794-2026
Official wording
Reason: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Code information: Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Distribution pattern: International distribution to the country of Poland.
Derived failure modes
-
Unknown
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.