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Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunction...

FDA Device Recall #Z-1971-2015 — Class II — May 29, 2015

Recall Summary

Recall Number Z-1971-2015
Classification Class II — Moderate risk
Date Initiated May 29, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Tecan US, Inc.
Location Morrisville, NC
Product Type Devices
Quantity 868 in total

Product Description

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.

Reason for Recall

A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

Distribution Pattern

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

Lot / 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

Other Recalls from Tecan US, Inc.

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Z-1851-2019 Class II Freedom EVO 200 - Product Usage: It is intended... Apr 12, 2019
Z-3187-2018 Class II Freedom EV0-2 with any version of EVOware and E... Jul 23, 2018
Z-2923-2018 Class II Cortisol Saliva Luminescence Immunoassay Th... Jan 12, 2018
Z-2661-2016 Class II SUNRISE instrument. The INFINITE F50 instrumen... Jul 25, 2016
Z-2664-2016 Class II Tecan Infinite M1000 The Tecan Infinite M1000 ... Jul 25, 2016

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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