Device product
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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-1609-2026
Product summary
- Event
- Event 98555
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 685 boxes
- Official record key
device-enforcement:Z-1609-2026
Official wording
Reason: Due to the likely presence of contamination in well(s).
Code information: Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Distribution pattern: U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Derived failure modes
-
Unknown
Due to the likely presence of contamination in well(s).