fda
14 records
FDA Device Recall: Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, su
2019-07-03
Class II — Gas springs not always replaced within the interval specified.
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FDA Device Recall: Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Sali
2018-09-05
Class II — 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 stand...
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FDA Device Recall: SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader
2016-08-31
Class II — The batteries have the potential to overheating, melt or char.
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FDA Device Recall: Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional mono
2016-08-31
Class II — The batteries have the potential to overheating, melt or char.
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FDA Device Recall: Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromato
2016-08-31
Class II — The batteries have the potential to overheating, melt or char.
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FDA Device Recall: Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for t
2016-08-31
Class II — The batteries have the potential to overheating, melt or char.
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FDA Device Recall: Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500
2015-07-08
Class II — A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
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FDA Device Recall: Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite
2015-07-08
Class II — A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
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FDA Device Recall: Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M100
2015-07-08
Class II — A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
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FDA Device Recall: Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 20
2015-07-08
Class II — A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
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FDA Device Recall: Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader w
2015-01-21
Class III — Incorrect lumi firmware version installed (E.027 instead of V2.00)
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FDA Device Recall: Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with
2015-01-21
Class III — Incorrect lumi firmware version installed (E.027 instead of V2.00)
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FDA Device Recall: Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open au
2014-11-05
Class II — 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 disp...
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FDA Device Recall: Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the
2013-06-26
Class II — 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 ...
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ny_corps
1 records
NY Corp: TECAN US, LTD.
1987-05-19
FOREIGN BUSINESS CORPORATION | County: Westchester | Jurisdiction: North Carolina
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USASpending
1 records
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