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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
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