FDA-Device2026-04-01Class IIPROCESSING DEFECT
Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
OTHERNationwide distribution
Stop using Beckman Coulter MicroScan Neg MIC 56
Beckman Coulter has recalled MicroScan Neg MIC 56 antimicrobial susceptibility testing panels (Catalog C42464, Lot 2026-01-03) due to potential contamination in the test wells. These panels are used by laboratories to identify bacteria and test antibiotic resistance. Contaminated panels could produce inaccurate test results.
- Stop using MicroScan Neg MIC 56 panels with Catalog Number C42464 and Lot Number 2026-01-03.
- Contact Beckman Coulter or your laboratory supplier for instructions on returning or replacing affected panels.
- If results from these panels were already reported, notify the ordering physician or facility.
Hazard
Due to the likely presence of contamination in well(s).
Sold states
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Affected count
685 boxes
Manufactured in
2040 Enterprise Blvd, West Sacramento, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2026More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
- 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.
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