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U.S. Department of Health and Human Services

Class 3 Device Recall Infinite 200

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  Class 3 Device Recall Infinite 200 see related information
Date Initiated by Firm November 10, 2014
Date Posted January 15, 2015
Recall Status1 Terminated 3 on December 21, 2015
Recall Number Z-0991-2015
Recall Event ID 69739
Product Classification Fluorometer, for clinical use - Product Code KHO
Product Infinite 200
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: 30016056, Lot numbers: 708004532, 810007441, 906000758.
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
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.
Quantity in Commerce 8 units
Distribution Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Total Product Life Cycle TPLC Device Report
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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