Recall record at a glance
| Official record | Z-2219-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Exact Sciences Corporation |
| Report date | Jun 7, 2017 |
| Recall initiation date | Apr 28, 2017 |
| Quantity | 15 |
| Location | Madison, WI, United States |
Official product description
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
Why the product 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.
Distribution information
US to WI only
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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