FDA Device recall Z-2323-2012
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System
- FDA Device
- Class III
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class III recall of VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System by Trek Diagnostic Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2323-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-23 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Trek Diagnostic Systems |
| Distribution | 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, PR, RI, SD, TN, TX, VA, VT, WA, WI, WV, WY |
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.
Identifiers
| code_info | Software: Cat. 6133-30-3, Version 5.4.3. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2012%22
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