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U.S. Department of Health and Human Services

Class 2 Device Recall Infinite 200

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  Class 2 Device Recall Infinite 200 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-1971-2015
Recall Event ID 71352
Product Classification Fluorometer, for clinical use - Product Code KHO
Product Infinite 200 in vitro diagnostic.

Product Usage:
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 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.
Code Information Material Number 30016056.  Serial numbers 608000038 708002670 809004233 702000023 805005669 811008399 705000576 708002669 607000020 701000018 701000019 912003459 912003460 910001503 612000022 609000040 1003008013 707005001 811005538 908007099 912002703 903002644 906005248 706007165 710000525 708005547 606000059 812003043 1004000452 806006568 702000055 912002709 708004538 607000002 910004667 811002997 702000005 906002532 907001839 803002342 606000017 602000009 603000019 804005274 806006009 903000369 912001128 807006555 803006110 712003370 812003592 611000052 606000023 910001497 702000035 711008973 710006304 806006565 609000014 811001743 903000617 811008162 710006302 602000010 606000014 906005245 603000022 712003104 1006000210 1003004213 612000021 1001007577 606000057 606000060 807004920 702000033 810003503 907001838 912004835 712004196 812001432 605000009 807004921 910001506 905004260 611000001 1003000506 606000002 612000031 705009140 807004933 603000016 604000016 910006599 606000041 606000058 809003657 810007441 604000023 906005250 703000026 711003508 805005672 903005273 1005004932 711011958 712004195 802004558 703000009 1002003718 607000038 703000030 901006989 512000025 608000016 608000017 512000011 711011784 804000313 1004001238 711005298 706004794 901004028 906000751 906000752 607000036 610000003 912004849 709000580 612000033 812004163 710000341 709002724 1004000460 812001429 606000016 801004189 603000051 810000172 608000031 904003884 805005673 706002156 912004620 1003000498 706004795 907003871 608000007 706002155 703000027 605000031 809003661 1002003711 611000013 907003869 605000022 911000116 910001504 1004004207 907001844 909003373 1001007581 812003078 908006434 809004133 701000025 606000043 707005005 1005007027 910004659 1003008005 905000129 804002911 706001227 703000005 705008369 707005006 706004797 604000014 910001508 812003041 906006724 911005649 809002413 801004398 703000012 804007741 910008851 911005664 1005007024 811001744 602000041 604000007 809000305 706005557 806006007 901006987 912004844 701000016 1002001897 605000012 805004762 809006161 708005898 903005272 611000027 712002390 912004328 602000011 907003870 906005249 801008029 605000030 903005182 912004848 806004296 912002702 1003006072 809004232 609000034 709002268 1003000501 803006117 1003000503 705000578 702000048 912000536 706004792 901000869 809000302 907003872 912004614 1006002104 612000025 901005069 711003366 906004540 603000018 911002915 609000008 512000007 601000035 804000312 602000031 
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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