Recall Z-1967-2015— Tecan US, Inc.
Class II · Terminated
Class II FDA medical device recall by Tecan US, Inc., initiated 2015-05-29, terminated 2017-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: A firmware bug causes incorrect values to be displayed for specific measured luminescence values..
- Recalling firm
- Tecan US, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-29
- Terminated
- 2017-08-18
- Firm location
- Morrisville, NC, United States
Product 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.
Reason for recall
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Data sourced from openFDA. This site is unofficial and independent of the FDA.