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U.S. Department of Health and Human Services

Class 2 Device Recall Infinite F500

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  Class 2 Device Recall Infinite F500 see related information
Date Initiated by Firm May 29, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on August 18, 2017
Recall Number Z-1967-2015
Recall Event ID 71352
Product Classification Fluorometer, for clinical use - Product Code KHO
Product Infinite F500, in vitro diagnostic.

Product Usage:
The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.
Code Information Material Number 30019337.  Serial numbers 1212004416 1009002605 612000003 811002510 712004158 906000965 902005109 912003472 1103002583 1411007090 704000003 702000001 708000500 1003004146 1109000103 1412005124 805001219 911005026 708005532 705007195 810000248 1010001663 712004152 708005533 1412005709 1103003780 706004455 608000002 908000185 1009002604 1308001035 804005914 1311007600 804000984 705009034 1309003195 801008055 706007961 901006341 
Recalling Firm/
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
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
FDA Determined
Cause 2
Device Design
Action Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.
Quantity in Commerce 868 in total
Distribution US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
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.