Recall Z-0992-2015— Tecan US, Inc.
Class III · Terminated
Class III FDA medical device recall by Tecan US, Inc., initiated 2014-11-10, terminated 2015-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.. Reason: Incorrect lumi firmware version installed (E.027 instead of V2.00).
- Recalling firm
- Tecan US, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-11-10
- Terminated
- 2015-12-21
- Firm location
- Morrisville, NC, United States
Product description
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
Reason for recall
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Data sourced from openFDA. This site is unofficial and independent of the FDA.