Roche Recalls cobas m 511 Hematology Analyzer for Discrepant Results
Roche Diagnostics Hematology is recalling 17 cobas m 511 integrated hematology analyzers due to discrepant results in patients with severe microcytic anemia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Hematology is recalling 17 units of the cobas m 511 integrated hematology analyzer, Model Number 07261691190. The recall affects all systems with software version 1.0. The devices were distributed to Austria, France, Germany, Hong Kong, Japan, the Netherlands, Pakistan, Singapore, South Korea, Switzerland, Thailand, and Vietnam. There is no distribution in the United States.
The recall is due to reported discrepant results in patients with severe microcytic anemia, such as iron deficiency or thalassemia. The affected parameters include red blood cell count (RBC), hemoglobin concentration (HGB), mean corpuscular hemoglobin (MCH), hematocrit (HCT), and mean corpuscular volume (MCV). The cobas m 511 is a quantitative, automated analyzer intended for in vitro diagnostic use in clinical laboratories to count formed elements of blood and assess cell morphology.
Healthcare facilities and laboratories that possess these devices should contact Roche Diagnostics Hematology for instructions on how to proceed. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- 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 clin
- Manufacturer
- Roche Diagnostics Hematology
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All systems with software version 1.0
Distribution
Distribution scope not specified by the agency.
Related recalls
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02