cobas m 511 integrated hematology analyzer — Class II medical device recall Z-2557-2018
Terminated recall by Roche Diagnostics Hematology, reported 2018-08-01. Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalasse
| Recall number | Z-2557-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Hematology, Westborough, MA, United States |
| Recall initiated | 2018-05-07 |
| Classified | 2018-07-26 |
| Reported by FDA | 2018-08-01 |
| Terminated | 2020-05-12 |
| Countries outside the US | AT, CH, DE, FR, HK, JP, KR, NL, PK, SG, TH, VN |
| Quantity | 17 |
| Model numbers | 07261691190 |
Product
cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports the following parameters: RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, %NRBC, #NRBC, WBC, %NEUT, #NEUT, %LYMPH, #LYMPH, %MONO, #MONO, %EO, #EO, %BASO, #BASO, PLT, MPV, %RET, #RET, HGB-RET.
Reason for recall
Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RBC (red blood cell count), HGB (hemoglobin concentration), MCH (mean corpuscular hemoglobin), HCT (hematocrit), and MCV (mean corpuscular volume).
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.