FDA Device recall Z-3113-2017
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leuk…
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leuk… by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3113-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-26 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Catalog Number(s): LH 750 System - 6605632, A85570, A68807; LH 780 System - 723585, A90728, A68808; LH 500 system - 660…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3113-2017%22
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