Reported Jun 7, 2017 · Terminated
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing…
Exact Sciences Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exact Sciences Corporation · 441 Charmany Dr · Madison, WI · 53719-1234
Is this the product you have?
- 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
- Lot codes and dates
- Equipment ID / Serial Number
MIX-0051 / MX00002051MIX-0052 / MX00002032MIX-0053 / MX00002028MIX-0054 / MX00002052MIX-0055 / MX00002043MIX-0056 / MX00002040MIX-0057 / MX00002050MIX-0058 / MX00002036MIX-0059 / MX00002027MIX-0060 / MX00002015MIX-0061 / MX00002016MIX-0063 / MX00002039MIX-0064 / MX00002033MIX-0065 / MX00002053MIX-0066 / MX00002014
- Equipment ID / Serial Number
- Amount recalled
- 15
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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