FDAClass IIMay 25, 2022

MicroScan WalkAway-40 plus Instrument recall

MicroScan WalkAway-40 plus Instrument REF B1018-283

Why was MicroScan WalkAway-40 plus Instrument recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MicroScan WalkAway-40 plus Instrument REF B1018-283
Recalling firm
Beckman Coulter Inc.
Quantity
22 systems
Distribution
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.
Recall date
May 25, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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