The Recall Desk
HighFDA (Devices)·Z-1088-2022·Announced 2022-05-25

MicroScan WalkAway-96 Plus Reconditioned Instruments Recalled for Incorrect Power Connector Rating

Beckman Coulter is recalling four MicroScan WalkAway-96 Plus systems that may have been assembled with a power connector rated at 1 ampere instead of the correct 10 amperes, creating an electrical hazard risk.

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 is a Class II FDA recall of a medical device with an electrical power connector safety defect that poses a risk of overheating or failure. No illnesses or injuries have been reported, and the hazard is theoretical rather than proven harm, meeting the criterion for High severity.

Plain-English summary

Beckman Coulter Inc. is recalling four MicroScan WalkAway-96 Plus Reconditioned Instruments (Model B1018-396R) due to an assembly defect affecting the AC power entry connector.

The instruments may have been assembled with an AC power entry connector inlet rated for 1 ampere instead of the correct 10 ampere rating. This electrical defect creates a risk of connector overheating, failure, or other electrical hazards during normal operation.

The affected instruments have serial numbers 39620362, 39620406, 3967731, and 3967914. These systems have been distributed to healthcare facilities and laboratories worldwide and throughout the United States.

Facilities operating these systems should immediately discontinue use and contact Beckman Coulter Inc. for information on obtaining replacements or repairs. Affected devices can be identified by Catalog Number B1018-396R and UDI-DI Code 15099590684129.

The recalled product

Product
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Clinical Microbiology
Hazard
Affected units
4

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 →

Related recalls

Same manufacturer · Beckman Coulter Inc.

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Same hazard · electrical hazard

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