FDAFDA · Food and drugs·Recall number Z-2219-2017
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
Published June 7, 2017 · Recall initiated: April 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exact Sciences Corporation
- Distributor
- US to WI only
- Lot
- Equipment ID / Serial Number: MIX-0051 / MX00002051, MIX-0052 / MX00002032, MIX-0053 / MX00002028, MIX-0054 / MX00002052, MIX-0055 / MX00002043, MIX-0056 / MX00002040, MIX-0057 / MX00002050, MIX-0058 / MX00002036, MIX-0059 / MX00002027, MIX-0060 / MX00002015, MIX-0061 / MX00002016, MIX-0063 / MX00002039, MIX-0064 / MX00002033, MIX-0065 / MX00002053, MIX-0066 / MX00002014,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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