FDA-Device2017-06-07Class II
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
Exact Sciences Corporation
Hazard
Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid makes contact with the Sample Mixer door.
Sold states
US to WI only
Affected count
15
Manufactured in
441 Charmany Dr, Madison, WI, United States
Products
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2017Don't want to check this manually?
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