Infinite 200 in vitro diagnostic
Medical device recall Z-1971-2015. Published in FDA’s Enforcement Report on Jul 8, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 8, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 42 states named
- 868 in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
868 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Material Number 30016056. Serial numbers 608000038 708002670 809004233 702000023 805005669 811008399 705000576 708002669 607000020 701000018 701000019 912003459 912003460 910001503 612000022 609000040 1003008013 707005001 811005538…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 2,502 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
42 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 29, 2015.
- FDA classified it on Jul 2, 2015.
- FDA’s Enforcement Report published it on Jul 8, 2015.
- FDA terminated it on Aug 18, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Tecan US, Inc., of Morrisville, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,502 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.