Coulter LH 750 Hematology Analyzer — Class II medical device recall Z-0470-2014
Terminated recall by Beckman Coulter Inc., reported 2013-12-18, distributed nationwide. Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may pote
| Recall number | Z-0470-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-11-08 |
| Classified | 2013-12-09 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-12-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BM, CH, CN, CO, CZ, DE, DZ, EC, EG, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, LV, MA, MX, MY, NL, NZ, PA, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UY, VE, VN, ZA |
| Reason classes | specification failure |
| Model numbers | 6605632, A85570 |
Product
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides 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
Reason for recall
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.
Machine access
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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.