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U.S. Department of Health and Human Services

Class 2 Device Recall Exact Sciences Sample Mixer 2

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  Class 2 Device Recall Exact Sciences Sample Mixer 2 see related information
Date Initiated by Firm April 28, 2017
Date Posted June 01, 2017
Recall Status1 Terminated 3 on August 11, 2017
Recall Number Z-2219-2017
Recall Event ID 77260
PMA Number P130017 
Product Classification System, colorectal neoplasia, DNA methylation and hemoglobin detection - Product Code PHP
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
Code Information 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,
Recalling Firm/
Manufacturer		 Exact Sciences Corporation
441 Charmany Dr
Madison WI 53719-1234
For Additional Information Contact Neelone Cestkowski
608-210-5183
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 15
Distribution US to WI only
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = PHP and Original Applicant = Exact Sciences Corporation
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