Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
VersaTREK Windows Software Recalled by Trek Diagnostic Systems Due to Review of instrument software databases and investigation of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Trek Diagnostic Systems directly.
Affected Products
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.
Quantity: 333 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 38 states: AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, WY
About Trek Diagnostic Systems
Trek Diagnostic Systems has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report