FDA-Device2026-04-15Class II
MicroScan Neg MIC 3J REF C54814
Beckman Coulter, Inc.
Hazard
Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics
Sold states
International distribution in the country of Japan.
Affected count
688 boxes (20 panels per box)
Manufactured in
2040 Enterprise Blvd, West Sacramento, CA, United States
Products
MicroScan Neg MIC 3J REF C54814
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1772-2026Original summary
MicroScan Neg MIC 3J REF C54814 Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23 Distribution: International distribution in the country of Japan. Affected quantity: 688 boxes (20 panels per box)
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