www.fdanews.com/articles/189317-fda-declares-beckman-coulters-flow-cytometer-recall-class-1
FDA Declares Beckman Coulter’s Flow Cytometer Recall Class 1
November 27, 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.