MicroScan recallZ-1085-2022 · Beckman Coulter Inc. · initiated Oct 21, 2019

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

FDA root cause category: Mixed-up of materials/components

What the company is doing

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: [email protected] 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.

Recall details

Recall number

Z-1085-2022

Status

Open, Classified

Initiated by the company

Oct 21, 2019

Recalling firm

Beckman Coulter Inc.

Quantity

40 systems

Product code

LRG

FDA submissions

K911400

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.

Product description

DxM 1040 MicroScan WalkAway Instrument REF B1018-440

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• MicroScan B1018-440

  Beckman Coulter, Inc. · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
  1 recall1 death2 reports

Product lines

• MicroScanBeckman Coulter, Inc. · 10 models · 7 reports · 9 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 90087).

• Z-1084-2022 · Open, Classified
  MicroScan WalkAway-96 plus Instrument REF B1018-284
• Z-1086-2022 · Open, Classified
  DxM 1096 MicroScan WalkAway Instrument REF B1018-496