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Medical Devices / Regulatory Affairs

FDA Declares Beckman Coulter’s Flow Cytometer Recall Class 1

Nov. 28, 2018

The FDA categorized Beckman Coulter Life Sciences’ recall of its flow cytometer devices as a Class 1 recall, noting that use of the products poses a reasonable risk of serious adverse health consequences or death.

The devices included in the recall are BCLS’ FC 500 series flow cytometers, Coulter EPICS XL and Coulter EPICS XL-MCL flow cytometer with system II software.

The company said that a component on the recalled devices’ circuit amplifier boards exhibits potential intermittent or permanent failure, which could impact all assays run on the devices for any application, including lab tests.

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