FDA-Device2026-04-15Class IIPROCESSING DEFECT
Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
OTHERNationwide distribution
Stop using Beckman Coulter MicroScan panels
Beckman Coulter identified a manufacturing defect in certain MicroScan Neg MIC 3J antibiotic susceptibility test panels (Catalog C54814, Lot 2025-08-23). Some panels are missing a drug in one well and contain double the amount of antibiotics in others, which could produce inaccurate test results. No injuries have been reported.
- Stop using MicroScan Neg MIC 3J panels with Catalog Number C54814 and Lot Number 2025-08-23
- Contact Beckman Coulter for instructions on return or disposal
- Review any patient test results from affected panels with your laboratory director
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-1772-2026More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15MicroScan 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.
- FDA-Device2026-04-01Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief