Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.
Recall
- Recall Number
- Z-1967-2015
- Event Number
- 71352
- Firm
- Tecan US, Inc.
- FEI Number
- 1037985
- Product Code
- KHO
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 29, 2015
- Posted
- July 2, 2015
- Terminated
- August 18, 2017
- Address
- 9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560
Description
Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.
US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
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