Medical device recalls

Tecan US, Inc. recalls Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 pr…

Recall date
November 10, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0992-2015
FDA classification
Class III
Brand / firm
Tecan US, Inc.
Sold / distributed
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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