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U.S. Department of Health and Human Services

Class 2 Device Recall Infinite M1000

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  Class 2 Device Recall Infinite M1000 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-1969-2015
Recall Event ID 71352
Product Classification Fluorometer, for clinical use - Product Code KHO
Product Infinite M1000 in vitro diagnostic.

Product Usage:
The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
Code Information Material Number 30034301 and 30061442.  Serial numbers 904004848 807001164 1003005106 808056058 1006007069 1108006370 906001927 811005550 1002002705 1007007321 1110004989 1009005297 910008892 1005008056 1103008195 1009003991 912003102 1007005488 912003960 1008001833 808052054 1005002244 1103001072 909005818 1005008057 1010005921 1004003572 1103008191 1001006206 809004189 907004270 1006007071 1010001688 1010001689 1110004987 1112000054 1107006152 1103008189 902000004 810003913 908006454 1002002702 912003958 1009002602 1007003513 1001007642 1110006961 911008985 908001687 1011003332 909007802 901005834 901005835 1009007093 906000659 812003360 1110004988 1009002603 1001006205 1003005108 1005008055 1112000053 1001001581 1005008053 1003000532 909000550 911000226 910004186 1009003980 1110006962 907000033 907000720 908004917 1001007641 910008890 808052053 808054758 901005836 911006512 1002002703 1003005107 1106008462 912000502 1010005918 909000551 807003935 807003936 907004267 1007007320 
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		 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.
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