FDA-Device2022-11-30Class II
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Beckman Coulter, Inc.
Hazard
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
Sold states
Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI MS, MT, NC, NE, PA, SC, TX WA, WI, and WV. The countries of Chile, Germany, Indonesia, Italy, Japan, Mexico, Peru, Portugal, South Africa, Spain, United Kingdom of Great Britain and Northern Ireland, and Uruguay.
Affected count
53 plates
Manufactured in
2040 Enterprise Blvd, N/A, West Sacramento, CA, United States
Products
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2023Don't want to check this manually?
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