Z-0991-2015 Class III Terminated
FDA device recall Z-0991-2015 was initiated by Tecan US, Inc. on November 10, 2014 and is designated Class III. Reason for recall: Incorrect lumi firmware version installed (E.027 instead of V2.00) The recall status is terminated (terminated December 21, 2015). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- November 10, 2014
- Termination Date
- December 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Infinite 200 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)
Distribution Pattern
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Code Information
Material number: 30016056, Lot numbers: 708004532, 810007441, 906000758.