The Recall Desk
HighFDA (Devices)·Z-1086-2022·Announced 2022-05-25

Medical analyzer instruments recalled for incorrect power connector rating

Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety 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 an FDA Class II recall of medical equipment with a potential electrical safety hazard from an undersized power connector. No illnesses or injuries have been reported, so the score is 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Beckman Coulter Inc. is recalling 49 DxM 1096 MicroScan WalkAway Instruments because some units may have been assembled with an incorrect AC power entry connector inlet. The connector is rated for 1 ampere of current instead of the correct 10 ampere rating.

This electrical safety defect could pose a risk during device operation. The affected instruments have been distributed worldwide, including throughout the United States and to multiple countries.

If you have one of the affected instruments, contact Beckman Coulter Inc. immediately. Do not use the device until it has been inspected and corrected by the manufacturer.

The recalled product

Product
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — Laboratory Analyzer
Hazard
  • electrical-safety
  • fire-hazard

Distribution

Distributed nationwide across the United States.

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