FDA Device Intelligence
HomeDevice types › JQW

Station, Pipetting And Diluting, For Clinical Use

FDA product code JQW · Class 1 · Clinical Chemistry

275
Registered devices
358
Adverse events
36
Recalls
140
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2021-01-15Hamilton CoThere is a risk that the device can start a fire if flammable liquids contact and enter the device.
2019-04-12Tecan US, Inc.Gas springs not always replaced within the interval specified.
2018-07-23Tecan US, Inc.There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sampl
2017-08-02Perkinelmer Life Sciences, Inc.We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing production final acceptance testing due to a Horizont
2017-06-27Hologic, IncA Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patie
2016-10-13PerkinElmer, IncDefective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
2016-06-24PerkinElmer, IncFilter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
2014-09-26Tecan US, Inc.Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. This might cause a false signal (air
2013-02-19Tecan US, Inc.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" followin
2012-04-11Beckman Coulter Inc.The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the AutoMa

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.