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Beckman Coulter Inc. recalls AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for
Recalled September 27, 2017 · FDA recall Z-3135-2017 · Beckman Coulter
Hazard
Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples. · FDA Class II
Units
213 units (34 units in the US)
Sold at
Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia
Description
Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
Product
AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →