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JANUS G3
Caliper Life Sciences, Inc. · Model CJM8M01 · UDI-DI 00812589020719
10
510(k) clearances
358
Adverse events
36
Recalls
70
Facilities
Description
JANUS G3 Standard, 8-tip + MDT, IVD
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-01-15 | Hamilton Co | There is a risk that the device can start a fire if flammable liquids contact and enter the device. |
| 2019-04-12 | Tecan US, Inc. | Gas springs not always replaced within the interval specified. |
| 2018-07-23 | Tecan US, Inc. | 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 In |
| 2017-08-02 | Perkinelmer 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 Horizontal Motion Error mes |
| 2017-06-27 | Hologic, Inc | A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results. |
| 2016-10-13 | PerkinElmer, Inc | Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips. |
| 2016-06-24 | PerkinElmer, Inc | Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing |
| 2014-09-26 | Tecan 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 detection) with poss |
| 2013-02-19 | Tecan 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" following a Rich User Prompt |
| 2012-04-11 | Beckman 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 AutoMate 2500 Family (prev |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.