Recall Z-1970-2015— 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 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates 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 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates 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.