Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall VersaTREK Windows Software, Version 5.4.3

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall VersaTREK Windows Software, Version 5.4.3 see related information
Date Initiated by Firm July 23, 2012
Date Posted September 06, 2012
Recall Status1 Terminated 3 on June 18, 2013
Recall Number Z-2323-2012
Recall Event ID 62757
510(K)Number K032306  
Product Classification System, blood culturing - Product Code MDB
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.
Code Information Software: Cat. 6133-30-3, Version 5.4.3.
Recalling Firm/
Manufacturer		 Trek Diagnostic Systems
982 Keynote Cir Ste 6
Cleveland OH 44131-1873
For Additional Information Contact Earlene C. Parks
913-985-4185
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action ThermoFisher Scientific sent an Important Medical Device Product Correction Notice dated July 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact the Technical Service Department at 800-642-7029 to schedule their upgrade and to complete and return the Correction Notice Customer Acknowledgement by fax or in the enclosed return envelope. Customers were also asked to return the checklist. For questions customers were instructed to call 800-642-7029. For questions regarding this recall call 913-985-4185.
Quantity in Commerce 333 units
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MDB and Original Applicant = TREK DIAGNOSTIC SYSTEMS, INC.
-
-