FDA-Device2015-01-21Class III

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.

Tecan US, Inc.
Hazard

Incorrect lumi firmware version installed (E.027 instead of V2.00)

Sold states
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Affected count
8 units
Manufactured in
9401 Globe Center Drive, Suite 140, Morrisville, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0991-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief