Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX… — Class II medical device recall Z-3114-2017
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-3114-2017 |
|---|---|
| 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 | 3,326 units |
| Model numbers | 178832, 178833, 178834, A90994, A91062 |
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 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-3114-2017. 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.