—#193358

Product

MicroScan WalkAway-96 plus Instrument REF B1018-284

FDA product code: LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K911400
Affected lot / code info: Catalog Number: B1018-284 UDI-DI Code: 15099590658687 Serial Numbers: 39610007 39610008 39610009 39610010 39610011 39610012 39610013

Why it was 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

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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.

Timeline

Recall initiated: 2019-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.