Device product
MicroScan Neg MIC 3J REF C54814
Z-1772-2026
Product summary
- Event
- Event 98553
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 688 boxes (20 panels per box)
- Official record key
device-enforcement:Z-1772-2026
Official wording
Reason: Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Code information: Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23
Distribution pattern: International distribution in the country of Japan.
Derived failure modes
-
Unknown
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics