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Recall Observatory FDA recall evidence

Device product

AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).

Z-2035-2017

April 03, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 76961
Status
Terminated
Classification
Class II
Quantity
188 units total (24 units in US)
Official record key
device-enforcement:Z-2035-2017

Official wording

Reason: Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.

Code information: All

Distribution pattern: Worldwide - US Nationwide in the countries of: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Kingdom and Zambia

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.