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.
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 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.
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