FDA-Device2026-04-01Class II
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.
Beckman Coulter, Inc.
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-1609-2026Original summary
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. Due to the likely presence of contamination in well(s). Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03 Distribution: U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX. Affected quantity: 685 boxes
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