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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 4
Distribution
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.
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