VersaTREK Windows Software — Class III medical device recall Z-2323-2012
Terminated recall by Trek Diagnostic Systems, reported 2012-09-12, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Review of instrument software databases and investigation of two customer reports determined that on rare occa
| Recall number | Z-2323-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trek Diagnostic Systems, Cleveland, OH, United States |
| Recall initiated | 2012-07-23 |
| Classified | 2012-09-06 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2013-06-18 |
| Distributed | 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 |
| Countries outside the US | BD, BR, BS, CA, CL, CN, CO, CZ, ES, FR, GB, IE, IN, IT, JO, JP, KE, KW, MX, MY, PE, PH, PK, PT, TH, TR, ZA |
| Quantity | 333 units |
| Reason classes | software |
| Model numbers | 6133-30-3 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2323-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.