Z-2323-2012Class III

VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be...

Name: Z-2323-2012 VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be...
Creator: Trek Diagnostic Systems
Published: 2012-07-23
License: https://open.fda.gov/license/

Trek Diagnostic Systems, Ltd. / initiated 2012-07-23 / Terminated / root cause: software

FDA source

Trek Diagnostic Systems began a recall of 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... on 2012-07-23. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2323-2012
Classification: Class III
Status: Terminated
Initiated: 2012-07-23
Posted: 2012-09-06
Terminated: 2013-06-18
Recalling firm: Trek Diagnostic Systems, Ltd.
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.
Product code: MDB System, Blood Culturing
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: Software: Cat. 6133-30-3, Version 5.4.3.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2323-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2323-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code MDB

K032306Class IVersatrekTrek Diagnostic Systems, Inc. / cleared 2003-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)