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Recall Observatory FDA recall evidence

Device product

MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R

Z-1088-2022

October 21, 2019

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 90087
Status
Ongoing
Classification
Class II
Quantity
4 systems
Official record key
device-enforcement:Z-1088-2022

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: B1018-396R UDI-DI Code: 15099590684129 Serial Numbers: 39620362 39620406 3967731 3967914

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