Tecan US, Inc.
Complete recall history across all FDA and CPSC categories — 19 total recalls
Tecan US, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (19)
FDA medical device enforcement actions by Tecan US, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 12, 2019 | Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks,... | Gas springs not always replaced within the interval specified. | Class II |
| Jul 23, 2018 | Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On ... | There is a software issue that can potentially impact sample identification a... | Class II |
| Jan 12, 2018 | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol S... | Product is not meeting specification for traceability to NIST cortisol standa... | Class II |
| Jul 25, 2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance... | The batteries have the potential to overheating, melt or char. | Class II |
| Jul 25, 2016 | Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate ... | The batteries have the potential to overheating, melt or char. | Class II |
| Jul 25, 2016 | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The... | The batteries have the potential to overheating, melt or char. | Class II |
| Jul 25, 2016 | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader fo... | The batteries have the potential to overheating, melt or char. | Class II |
| Jul 25, 2016 | Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochrom... | The batteries have the potential to overheating, melt or char. | Class II |
| Jul 25, 2016 | Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional m... | The batteries have the potential to overheating, melt or char. | Class II |
| Jul 25, 2016 | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance read... | The batteries have the potential to overheating, melt or char. | Class II |
| May 29, 2015 | Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 20... | A firmware bug causes incorrect values to be displayed for specific measured ... | Class II |
| May 29, 2015 | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite... | A firmware bug causes incorrect values to be displayed for specific measured ... | Class II |
| May 29, 2015 | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M... | A firmware bug causes incorrect values to be displayed for specific measured ... | Class II |
| May 29, 2015 | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infini... | A firmware bug causes incorrect values to be displayed for specific measured ... | Class II |
| May 29, 2015 | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F... | A firmware bug causes incorrect values to be displayed for specific measured ... | Class II |
| Nov 10, 2014 | Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader w... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III |
| Nov 10, 2014 | Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reade... | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III |
| Sep 26, 2014 | Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open... | Distortion (noise interference) of the liquid level capacitance can result in... | Class II |
| Feb 19, 2013 | Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of ... | WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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