Trek Diagnostic Systems Recalls VersaTREK Windows Software Version 5.4.3
Trek Diagnostic Systems is recalling VersaTREK Windows Software Version 5.4.3 because positive test results may incorrectly revert to negative in the database.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The defect involves a software error that may lead to incorrect test results, but no injuries or illnesses have been reported.
Plain-English summary
Trek Diagnostic Systems is recalling VersaTREK Windows Software, Version 5.4.3, a component of the VersaTrek System used for cultivating and recovering microorganisms from blood and other sterile body fluids. The software is distributed on a CD and is used in conjunction with the VersaTREK instrument.
The recall was initiated after a review of instrument software databases and an investigation of two customer reports revealed that on rare occasions (less than 0.3%), positive test results may inadvertently revert to negative results in the instrument database following the removal of a positive signaling bottle. This defect could lead to the misinterpretation of test results.
The recall affects 333 units of the software, which were distributed worldwide, including in the United States and various international locations. Users of the VersaTREK System should contact Trek Diagnostic Systems for instructions on how to resolve the software issue.
The recalled product
- Product
- VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms…
- Manufacturer
- Trek Diagnostic Systems
- Affected units
- 333
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 (2)
- Software: Cat. 6133-30-3
- Version 5.4.3.
Distribution
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