Recall Z-2219-2017— Exact Sciences Corporation
Class II · Terminated
Class II FDA medical device recall by Exact Sciences Corporation, initiated 2017-04-28, terminated 2017-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Exact Sciences Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-28
- Terminated
- 2017-08-11
- Firm location
- Madison, WI, United States
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.