FDA-Device2022-05-25Class II
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
Beckman Coulter Inc.
Hazard
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
Sold states
Worldwide distribution - U.S. Nationwide distribution in the states of Alaska, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, and Washington. The countries of Belgium, Brazil, Colombia, Germany, Hong Kong, Indonesia, Italy, Japan, Paraguay, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, United Arab Emirates, Vietnam and Yemen.
Affected count
4 systems
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1088-2022Don't want to check this manually?
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