Coulter LH 750 — Class II medical device recall Z-3113-2017
Terminated recall by Beckman Coulter Inc., reported 2017-09-13, distributed nationwide. Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In r
| Recall number | Z-3113-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-06-26 |
| Classified | 2017-09-07 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2023-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BM, BR, CA, CN, CO, CZ, DE, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IN, IQ, IS, IT, JO, JP, KE, KW, LB, LK, LT, MA, MX, MY, NG, NL, NZ, PA, PH, PK, PT, PY, QA, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TT, TW, UY, VE, VN, ZA |
| Quantity | 6,763 units |
| Model numbers | 750 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3113-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.