FDA Device recall Z-3114-2017
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal s…
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal s… 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-3114-2017 |
| 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 HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology 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, biochemical investigation or any other test that helps diagnose the 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): HMX CP - 178832, 178833, 178834, A91062, A90994; HmX AutoLoader - 6605522, 6605523, 6605524; 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-3114-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.