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Exact Sciences Corporation recalls Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing s

Recalled June 7, 2017 · FDA recall Z-2219-2017 · Exact Sciences

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. · FDA Class II
Units
15
Sold at
US to WI only

Description

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.

Product
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
Manufacturer(s)
Exact Sciences Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Exact Sciences Corporation recalls Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing s | RecallWatchUSA