The Recall Desk
HighFDA (Devices)·Z-1083-2022·Announced 2022-05-25

MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector

Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a potential electrical hazard (undersized AC power connector on a medical device that could cause overheating or fire), but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored at 3 (High).

Plain-English summary

Beckman Coulter Inc. is recalling 22 MicroScan WalkAway-40 plus Instruments (Catalog Number B1018-283) that were assembled with an incorrect AC power entry connector inlet. The connector was rated for 1 ampere of current instead of the required 10 amperes.

A power connector with an undersized current rating can overheat or fail when operating at normal power levels, potentially creating an electrical fire hazard or causing the device to malfunction unexpectedly.

The affected units, identified by serial numbers 34010003 through 34010024, have been distributed worldwide, including throughout the United States and to countries including 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. No illnesses or injuries related to this issue have been reported.

Facilities using affected instruments should contact Beckman Coulter Inc. for instructions on inspection, replacement, or remedial action. Healthcare providers and laboratory personnel should verify their device serial numbers against the recall notice and follow the manufacturer's guidance immediately.

The recalled product

Product
MicroScan WalkAway-40 plus Instrument REF B1018-283
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Instrument
Hazard
Affected units
22

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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Same hazard · electrical hazard

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