Recall Z-2323-2012— Trek Diagnostic Systems

Name: FDA recall Z-2323-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-23

Class III · Terminated

Class III FDA medical device recall by Trek Diagnostic Systems, initiated 2012-07-23, terminated 2013-06-18. It names one FDA 510(k) clearance: K032306. 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.. 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: Trek Diagnostic Systems
Classification: Class III
Status: Terminated
Initiated: 2012-07-23
Terminated: 2013-06-18
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K032306 — VERSATREKTrek Diagnostic Systems, Inc.·cleared 2003-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.