Tecan U.S.
Morrisville, NC, US
TECAN U.S. appears in FDA device records in Morrisville, NC. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 22 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Tecan U.S. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Tecan U S Increcall
510(k) clearance history
FDA records hold 10 510(k) clearances for Tecan U.S. between 1986 and 1997. The busiest year on record is 1994, with 3. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 3 |
| 1995 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K963268 | GENESIS RMP | JRA | Substantially Equivalent | |
| K953345 | GENESIS | JQW | Substantially Equivalent | |
| K944556 | 4 CHANNEL DISPENSER | JQW | Substantially Equivalent | |
| K942655 | 4 CHANNEL DISPENSER | JQW | Substantially Equivalent | |
| K933996 | PROFIBLOT | KPA | Substantially Equivalent | |
| K915492 | RSP MEGA SAMPLE PROCESSOR | JQW | Substantially Equivalent | |
| K912036 | ROBOTIC SAMPLE PROCESSOR | JQW | Substantially Equivalent | |
| K910740 | SLT MICROPLATE WASHER | JJQ | Substantially Equivalent | |
| K894126 | ROBOTIC SAMPLE PROCESSOR | JQW | Substantially Equivalent | |
| K854406 | TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 | JQW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037985 | 1037985 | TECAN U.S. | 9401 Globe Center Dr Ste 140, Morrisville, NC 27560 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1851-2019 | Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. | Gas springs not always replaced within the interval specified. | Class II | Terminated | |
| Z-3187-2018 | Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher | There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher, Part Number 30019971. | Class II | Terminated | |
| Z-2923-2018 | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings. | Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard. | Class II | Terminated | |
| Z-2666-2016 | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma). | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-2665-2016 | Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards. | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-2664-2016 | Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as an external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANSI/SBS standards | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-2663-2016 | Infinite 200 PRO 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 ANSI/SBS standards. | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-2662-2016 | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics. | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-2661-2016 | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-2660-2016 | Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics | The batteries have the potential to overheating, melt or char. | Class II | Terminated | |
| Z-1971-2015 | 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. | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Terminated | |
| Z-1970-2015 | 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. | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Terminated | |
| Z-1969-2015 | Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards. | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Terminated | |
| Z-1968-2015 | Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards. | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Terminated | |
| Z-1967-2015 | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards. | A firmware bug causes incorrect values to be displayed for specific measured luminescence values. | Class II | Terminated | |
| Z-0992-2015 | Infinite 200PRO 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 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards. | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Terminated | |
| Z-0991-2015 | Infinite 200 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 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards. | Incorrect lumi firmware version installed (E.027 instead of V2.00) | Class III | Terminated | |
| Z-0149-2015 | Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. | Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air detection) with possible dispense errors resulting in erroneous results. | Class II | Terminated | |
| Z-1560-2013 | Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument. | WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses "Continue" following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside t | Class II | Terminated | |
| Z-0326-06 | Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestrae 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Blister 1 x 96 pcs. | Double filtering of 1000 l tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples. | Terminated | ||
| Z-1022-04 | Tecan Clinical Workstations with Robonet software | Tecan software has the potential to match the patient with a different patient's test results. | Terminated | ||
| Z-0869-03 | Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower. | Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain