Reported Sep 12, 2012 · Terminated
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually…
Trek Diagnostic Systems
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trek Diagnostic Systems · 982 Keynote Cir Ste 6 · Cleveland, OH · 44131-1873
Is this the product you have?
- 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.
- Lot codes and dates
- Software
Cat. 6133-30-3Version 5.4.3
- Software
- Amount recalled
- 333 units
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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