Medical DeviceJul 3, 2019
Tecan US Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such recall — FDA Z-1851-2019
Gas springs not always replaced within the interval specified.
Class IIFDA: TerminatedTecan US, Inc.
Recall history in this database
Classification mix: Class II: 3.
Medical DeviceSep 26, 2018
Tecan US Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 recall — FDA Z-3187-2018
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…
Class IIFDA: TerminatedTecan US, Inc.
Medical DeviceSep 5, 2018
Tecan US Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva recall — FDA Z-2923-2018
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…
Class IIFDA: TerminatedTecan US, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Tecan US, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.