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
FDA Recall Z-2219-2017 · Posted 2017-06-01
Recalling FirmExact Sciences Corporation
Recall StatusTerminated
Product CodePHP
Date Initiated2017-04-28
Date Terminated2017-08-11
Product Quantity15
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.
Firm Action
Exact Sciences sent an Urgent Medical Device Correction letter dated April 28, 2017, via email to all affected consignees. The letter identified affected products and explained the issue. Exact Sciences personnel will correct each unit. Questions can be directed to 608-210-5183.
Root Cause
Device Design
Distribution Pattern
US to WI only
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.