Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provid

FDA device recall Z-0991-2015 · posted 2015-01-15 · Terminated

Recall details

Recalling firm

Tecan US, Inc.

Reason for recall

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

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.

Root cause

Employee error

Status

Terminated

Product code

KHO

Quantity affected

8 units

Distribution

Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.

Date initiated

2014-11-10

Date posted

2015-01-15

Date terminated

2015-12-21

Location

Morrisville, NC