Home / Recalls / Beckman Coulter Inc. / Z-2035-2017

Z-2035-2017 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

FDA device recall Z-2035-2017 was initiated by Beckman Coulter Inc. on April 3, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 7, 2017). Affected quantity: 188 units total (24 units in US).

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
April 3, 2017
Termination Date
August 7, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
188 units total (24 units in US)

Product Description

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).

Reason for Recall

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.

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

Code Information

All

Other recalls by Beckman Coulter Inc.

  • Z-2888-2026 Class II — REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed (June 26, 2026)
  • Z-2889-2026 Class II — REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi (June 26, 2026)
  • Z-1922-2026 Class II — Access Total T4 Calibrator, Catalog No. 33805 (March 16, 2026)
  • Z-1235-2026 Class II — CellMek SPS Sample Preparation System, REF: C44603, with software (December 23, 2025)
  • Z-1025-2026 Class II — Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoas (November 26, 2025)
  • Z-1026-2026 Class II — Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; (November 26, 2025)
  • Z-1221-2026 Class II — COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use a (November 10, 2025)
  • Z-0889-2026 Class II — Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process (November 7, 2025)
  • Z-0429-2026 Class II — Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemi (October 1, 2025)
  • Z-0428-2026 Class II — Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemi (October 1, 2025)

FDA data resources