Home / Recalls / Beckman Coulter Inc. / Z-0032-2026

Z-0032-2026 Class II Ongoing

Recalled by Beckman Coulter Inc. — Brea, CA

FDA device recall Z-0032-2026 was initiated by Beckman Coulter Inc. on August 4, 2025 and is designated Class II. Reason for recall: On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will r… The recall status is ongoing. Affected quantity: 116.

Recall Details

Product Type
Devices
Report Date
October 8, 2025
Initiation Date
August 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
116

Product Description

DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer

Reason for Recall

On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.

Distribution Pattern

Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom of Great Britain and Northern Ireland, Namibia, Turkey, Republic of Korea

Code Information

REF/UDI-DI: C63522/14987666545089, C63521/14987666545072. Software Versions: SW 1.3.3 and 1.3.4

Other recalls by Beckman Coulter Inc.

  • Z-2889-2026 Class II — REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the followi (June 26, 2026)
  • Z-2888-2026 Class II — REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed (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