Recall Z-0992-2015
Tecan US, Inc. · initiated November 10, 2014
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591.
Reason for recall
Incorrect lumi firmware version installed (E.027 instead of V2.00)
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0992-2015
- Initiated
- November 10, 2014
- Posted by FDA
- January 15, 2015
- Terminated
- December 21, 2015
- Product code
- KHO – Fluorometer, For Clinical Use
- Distribution
- Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
- Recalling firm
- Tecan US, Inc., Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0991-2015 Class III | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector…Incorrect lumi firmware version installed (E.027 instead of V2.00) | 11/10/2014Terminated |