Medical Device Recall: DYNEX Agility Analyzer Control Sample Aspiration Defect
Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.
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: This is a diagnostic device where a software defect creates a risk that incorrect control samples will be used during testing, potentially leading to delayed or inaccurate patient results. No illnesses or injuries have been reported; however, the potential for diagnostic error in a medical analyzer constitutes a risk-of-harm scenario that warrants High severity classification per the rubric.
Plain-English summary
The DYNEX Agility Analyzer, Model No. 67000, is being recalled due to a software defect affecting control sample aspiration. A total of 218 units were distributed worldwide, including to medical facilities across the United States and internationally.
The defect causes the Agility to aspirate control samples from the wrong SmartKit during testing. This creates a risk that a control sample from one assay's SmartKit will be used instead of the correct control sample, which may lead to delayed patient results.
Dynex Technologies has released a software update (v1.4.7) to correct the issue. Facilities using the affected software version (v1.4.3) should implement the update to prevent control sample mix-ups.
The recalled product
- Product
- DYNEX Agility, Agility Analyzer, Model No. 67000
- Manufacturer
- Dynex Technologies, Inc.
Distribution
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