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.
FDA Recall Z-0992-2015 · Posted 2015-01-15
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Recalling FirmTecan US, Inc.
Recall StatusTerminated
Product CodeKHO
Date Initiated2014-11-10
Date Terminated2015-12-21
Reason for Recall
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Firm Action
Tecan sent an Urgent Field Corrective Action letter dated October2014, to all affected consignees by via FedEx on/or about November 10, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use te kinetic luminescence measurement workflow requiring movement of th eplate transport out during kinectice measurements until the firmware has been upgraded to current version 2.0. A Tecan service representative will contact you to arrange a time to install the firmware. Additionally, they may want to review prior measurement results obtained with this workflow. Customers with questions were advised to contacte their local Tecan Helpdesk.
For questions regarding this recall call 919-361-5200, ext 19524.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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