FDAFDA · Food and drugs·Recall number Z-1083-2022
MicroScan WalkAway-40 plus Instrument REF B1018-283
Published May 25, 2022 · Recall initiated: October 21, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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