Date Initiated by Firm |
November 10, 2014 |
Date Posted |
January 15, 2015 |
Recall Status1 |
Terminated 3 on December 21, 2015 |
Recall Number |
Z-0992-2015 |
Recall Event ID |
69739 |
Product Classification |
Fluorometer, for clinical use - Product Code KHO
|
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. |
Code Information |
Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591. |
Recalling Firm/ Manufacturer |
Tecan US, Inc. 9401 Globe Center Drive Suite 140 Morrisville NC 27560
|
For Additional Information Contact |
Laura Nea 919-361-5200 Ext. 19524
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Manufacturer Reason for Recall |
Incorrect lumi firmware version installed (E.027 instead of V2.00)
|
FDA Determined Cause 2 |
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 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. |
Distribution |
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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