Home / Recalls / Beckman Coulter Inc. / Z-3113-2017

Z-3113-2017 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

Recall Details

Product Type
Devices
Report Date
September 13, 2017
Initiation Date
June 26, 2017
Termination Date
September 14, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6763 units

Product Description

Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormality

Reason for Recall

Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.

Distribution Pattern

Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.

Code Information

Catalog Number(s): LH 750 System - 6605632, A85570, A68807; LH 780 System - 723585, A90728, A68808; LH 500 system - 6605525, 6605526, 6605527, A85566, A85564; All software versions

Other recalls by Beckman Coulter Inc.

  • 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)
  • Z-0541-2026 Class II — DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The (September 22, 2025)
  • Z-0216-2026 Class II — DxI 9000 Access Immunoassay Analyzer, Part Number C11137 (September 19, 2025)