Infinite 200 PRO in vitro diagnostic
Medical device recall Z-1970-2015. 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 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO 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 30050303. Serial numbers 1501008516 1106001345 1301002808 1302009129 1110007010 1308006467 1211001078 1204007050 1401006368 1409008005 1412005114 1009003261 1210009373 1104000436 1009006192 1305001434 1310010334 1402000382…
Every code shown here, 1,999 characters
Material Number 30050303. Serial numbers 1501008516 1106001345 1301002808 1302009129 1110007010 1308006467 1211001078 1204007050 1401006368 1409008005 1412005114 1009003261 1210009373 1104000436 1009006192 1305001434 1310010334 1402000382 1410007778 1208006946 1007000392 1305010270 1405002521 1304005224 1401004534 1405006969 1111000103 1210007330 1502007386 1401007346 1412005118 1203003218 1007005229 1301007222 1006004109 1307006588 1311000218 1112005413 1305008099 1208009225 1212000034 1301009476 1311003918 1206001011 1212000035 1211009784 1403007992 1207007478 1201006124 1408006474 1408006475 1304000220 1401006366 1301009472 1401009553 1305004119 1108003415 1311000214 1309003843 1408002770 1403004653 1009006194 1306007913 1111007888 1009004379 1302001636 1105001261 1106002181 1208005752 1307006587 1112005785 1212004214 1402003539 1307001047 1410002321 1401009545 1409005578 1407000606 1112004304 1011004727 1011004728 1411004683 1407000614 1009004894 1009004895 1412005121 1105005792 1208002653 1101006577 1310006280 1202000758 1210005464 1405002507 1212003129 1404001420 1406007259 1411004208 1008006784 1301009464 1309003841 1405000435 1402006217 1201002015 1502003021 1211001056 1202007079 1305010252 1211007583 1402003536 1111009129 1311008588 1410002324 1010001510 1109001150 1304002474 1409002244 1409003931 1409003939 1409005599 1409005600 1412005115 1208007659 1208005753 1410004931 1206006103 1404001416 1304000215 1305008098 1405006967 1308006472 1403005482 1405002509 1211001181 1303009359 1309006759 1102001378 1310009096 1204007054 1308003257 1208005761 1201006112 1402006220 1406006649 1406006650 1408006482 1503000055 1307004560 1308003263 1111002443 1106005622 1301009473 1211009803 1203002542 1405002955 1407000830 1310001807 1211001182 1307002800 1210007324 1110002600 1202006470 1409003932 1409003933 1409003934 1412005692 1009003260 1108003821 1112003276 1009001469 1105007942 1108000027 1108003820 1311001420 1404001433 1104000437 1111001299 1308005785 1302001638…
FDA’s list runs to 3,703 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 3,703 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.