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Recall Observatory FDA recall evidence

Device product

MicroScan WalkAway-40 plus Instrument REF B1018-283

Z-1083-2022

October 21, 2019

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 90087
Status
Ongoing
Classification
Class II
Quantity
22 systems
Official record key
device-enforcement:Z-1083-2022

Official wording

Reason: 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

Code information: Catalog Number: B1018-283 UDI-DI Code: 1509959065866 Serial Numbers: 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016 34010017 34010018 34010019 34010020 34010021 34010022 34010023 34010024

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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