September 12, 2012Medical DevicesFDA
Trek Diagnostic Systems recalls VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually p
Hazard: Review of instrument software databases and investigation of two customer reports determined that on rare occasions (less than 0.3%), following the removal of a positive signaling bottle from the VersaTREK instrument, the positive test result inadvertently reverted to a negative result in the instrument database.