Medonic M-Series Hematology Analyzer Recalled for Sample Misidentification and Needle Injury Risk
Clinical Diagnostic Solutions is recalling Medonic M-Series Hematology Analyzers due to a risk of sample misidentification and operator injury from exposed needles.
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 involves a risk of operator injury from an exposed needle and sample misidentification, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Clinical Diagnostic Solutions, Inc. is recalling 261 units of the Medonic M-Series Hematology Analyzer M16S BD ABR US (Product code: 1400075; OUS Product code: 1400011). The recall affects all serial numbers distributed prior to March 21, 2019.
The recall was initiated because of a mix-up of autosampler tube positions, which creates a possibility of misidentifying sample results. Additionally, there is a risk of operator injury from an exposed aspiration needle.
The affected devices were distributed worldwide, including in the United States, Venezuela, Africa, Italy, Brazil, and Ukraine. The source text does not specify specific actions for consumers or operators, but the recall is managed by the recalling firm, Clinical Diagnostic Solutions, Inc.
The recalled product
- Product
- Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
- Affected units
- 261
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · needle injury
See all →- SevereCombat Medical Systems Recalls Valkyrie LTOWB Blood Administration Kits
FDA (Devices) · 2021-02-24
- SevereCombat Medical Systems Recalls Fresh Whole Blood Transfusion Sets
FDA (Devices) · 2021-02-24
- SevereCombat Medical Systems Recalls Valkyrie LTOWB Blood Collection Kits
FDA (Devices) · 2021-02-24
- CriticalCombat Medical Systems Recalls Fresh Whole Blood Donor Sets
FDA (Devices) · 2021-02-24
- HighValeritas Recalls DEMO No Needle Corrugated Cartons Due to Needle Risk
FDA (Devices) · 2019-11-06
Similar recalls
- HighSiemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- HighBiopsy Needle Recall Due to Compromised Sterility Assurance
FDA (Devices) · 2021-09-29
- HighSiemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk
FDA (Devices) · 2013-11-06
- LowClinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials
FDA (Devices) · 2012-11-14
- HighSiemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk
FDA (Devices) · 2013-11-06
- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22