Roche Diagnostics Hematology, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Roche Diagnostics Hematology, Inc. makes
Roche Diagnostics Hematology, Inc. manufactures integrated hematology analyzers, such as the cobas m 511, designed for automated blood cell counting and differential analysis in clinical laboratories.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
cobas m 511 integrated hematology analyzer Ref K171655
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Roche Diagnostics Hematology, Inc., initiated on 2018-05-07. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 7 May 2018 Z-2557-2018 Class II Terminated 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).
Full distribution text
- 7 May 2018 Z-2557-2018 Class II Terminated 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).
Frequently asked questions
How many devices does Roche Diagnostics Hematology, Inc. have in the registry?
The registry currently lists 1 device for Roche Diagnostics Hematology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Diagnostics Hematology, Inc.'s devices?
Among its 1 most recently registered device, Roche Diagnostics Hematology, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Roche Diagnostics Hematology, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Roche Diagnostics Hematology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Roche Diagnostics Hematology, Inc.?
FDA recall records list 1 recall initiated by Roche Diagnostics Hematology, Inc., the most recent initiated on 7 May 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Roche Diagnostics Hematology, Inc. in the registry?
The most recently registered devices listed for Roche Diagnostics Hematology, Inc. include cobas m 511 integrated hematology analyzer.