Beckman Coulter Inc.: MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R

Recall number

Z-1088-2022

Recalling firm

Beckman Coulter Inc.

Product

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

Status

Open, Classified

Initiated

2019-10-21

Posted

not on file

Terminated

not on file

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

Root cause

Mixed-up of materials/components

Action

During the week of 10/21/2019, Beckman Coulter sent an "URGENT MEDICAL DEVICE RECALL" Letter via e-mail and postal mail informing customers that some WalkAway instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1A (ampere) current rating rather than the correct current rating at 10A. Customers are instructed to: If the component fails and and the WalkAway suffers a power loss, user should: --Contact the Customer Support Center. If in the United States call 1-800-677-7226. If outside the United States, contact their local Beckman Coulter Representive. --Determine if the customer knows how long the WalkAway has been without power. If the time is unknown or greater than 2 hours, then panels should be reset, or an alternate test method should be used. -- If within 2 hours window the instrument will maintain the environmental conditions. Depending on the panel type, the user has the option to read the panels manually, on an autoSCAN-4 (if available) or reset the panels. - If the component remains functional, a Beckman Coulter Field Service Representative will contact the user to schedule an onsite visit. During the visit the representative will inspect the suspect instrument and if the incorrect component is found, will replace the component with the correct one rated at 10A. -Complete and return Customer Response Form to Beckman Coulter, Inc. 1584 Enterprise Blvd. West Sacramento, CA 95691 Attn: Quality Systems & Compliance Fax number: 916-374-2119 Email address: MicrobiologyCustomersHCUS@beckman.com For questions, contact: -via website, http://www.beckmancoulter.com/customersupport/support -via phone, call 1-800-677-7226 in the United States, -If outside the United States, contact the local Beckman Coulter Representative.

Quantity

4 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.

Lot, serial or model codes

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

510(k) numbers

["K911400"]

PMA numbers

not on file

Product code

LRG

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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