VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually p
FDA device recall Z-2323-2012 · posted 2012-09-06 · Terminated
Recall details
- Recalling firm
- Trek Diagnostic Systems
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 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. Inte
- Date initiated
- 2012-07-23
- Date posted
- 2012-09-06
- Date terminated
- 2013-06-18
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSATREK (K032306) | Trek Diagnostic Systems, Inc. | 2003-08-22 |