Z-2219-2017Class II

Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for...

Name: Z-2219-2017 Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for...
Creator: Exact Sciences Corporation
Published: 2017-04-28
License: https://open.fda.gov/license/

Exact Sciences Corporation- Innovation Campus / initiated 2017-04-28 / Terminated / root cause: design

FDA source

Exact Sciences Corporation began a recall of 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... on 2017-04-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2219-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Posted: 2017-06-01
Terminated: 2017-08-11
Recalling firm: Exact Sciences Corporation- Innovation Campus
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
Product code: PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2219-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2219-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01

Product code PHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)