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Z-2323-2012 Class III Terminated

Recalled by Trek Diagnostic Systems — Cleveland, OH

FDA device recall Z-2323-2012 was initiated by Trek Diagnostic Systems on July 23, 2012 and is designated Class III. 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 Vers… The recall status is terminated (terminated June 18, 2013). Affected quantity: 333 units.

Recall Details

Product Type: Devices
Report Date: September 12, 2012
Initiation Date: July 23, 2012
Termination Date: June 18, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 333 units

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.

Distribution Pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO , CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV, and WY. Internationally to the countries of Bahamas, Bangladesh, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Pakistan, Peru, Philippines, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, and United Kingdom

Code Information

Software: Cat. 6133-30-3, Version 5.4.3.