Company:Trek Diagnostic Systems
Date of Enforcement Report 9/12/12
Class lll:
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, especially bacteria and yeasts, from blood and other normally sterile body fluids. Z-2323-2012
REASON
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.
RECALLING FIRM/MANUFACTURER
Trek Diagnostic Systems,Cleveland OH on 7/23/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
333 units
DISTRIBUTION
Nationwide and Internationally
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