Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.
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 an FDA Class II medical device recall involving a potential electrical safety hazard from an underated power connector. Although no injuries have been reported, an undersized electrical connector in a medical device represents a risk-of-harm product that could fail during normal operation.
Plain-English summary
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments (Catalog Number B1018-284) due to an AC power connector assembly defect.
The affected instruments may have been assembled with an AC power entry connector inlet rated at 1 ampere instead of the correct 10 ampere rating. An underated connector could fail or overheat during normal operation, creating a potential electrical hazard.
The recall affects instruments with serial numbers 39610007 through 39610013, distributed worldwide including throughout the United States and to 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.
If you own an affected instrument, verify your serial number and contact Beckman Coulter Inc. immediately for instructions regarding replacement or corrective action.
The recalled product
- Product
- MicroScan WalkAway-96 plus Instrument REF B1018-284
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 7
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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