Derived label

Device software or design

Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: firmware bug causes incorrect
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Tecan US, Inc.