Recall Z-0992-2015 ยท KHO Fluorometer, For Clinical Use
Tecan US, Inc.
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
| Date | Jan 15, 2015 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | Incorrect lumi firmware version installed (E.027 instead of V2.00) |
| Root cause | Employee error |
| 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 measurem |
| Distribution | Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.