Home / Recalls / Beckman Coulter, Inc. / Z-1026-2026

Z-1026-2026 Class II Ongoing

Recalled by Beckman Coulter, Inc. — Chaska, MN

Recall Details

Product Type
Devices
Report Date
January 14, 2026
Initiation Date
November 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6457 units

Product Description

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

Reason for Recall

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.

Distribution Pattern

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.

Code Information

973100: UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou); A71456: UDI 15099590369194; A71457: UDI 15099590369231; A25288: UDI 15099590194819

Other recalls by Beckman Coulter, Inc.

  • 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-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-0428-2026 Class II — Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemi (October 1, 2025)
  • Z-0429-2026 Class II — Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemi (October 1, 2025)
  • Z-0541-2026 Class II — DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The (September 22, 2025)
  • Z-0215-2026 Class II — DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Numb (September 19, 2025)
  • Z-0216-2026 Class II — DxI 9000 Access Immunoassay Analyzer, Part Number C11137 (September 19, 2025)
  • Z-0441-2026 Class II — SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 (September 17, 2025)