Exact Sciences Sample Mixer 2 — Class II medical device recall Z-2219-2017
Terminated recall by Exact Sciences Corporation, reported 2017-06-07, distributed in WI. Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damag
| Recall number | Z-2219-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exact Sciences Corporation, Madison, WI, United States |
| Recall initiated | 2017-04-28 |
| Classified | 2017-06-01 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-08-11 |
| Distributed | WI |
| Quantity | 15 |
| Serial numbers | MIX-0051, MIX-0052, MIX-0053, MIX-0054, MIX-0055, MIX-0056, MIX-0057, MIX-0058, MIX-0059, MIX-0060, MIX-0061, MIX-0063, MIX-0064, MIX-0065, MIX-0066, MX00002014, MX00002015, MX00002016, MX00002027, MX00002028, MX00002032, MX00002033, MX00002036, MX00002039, MX00002040 and 5 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2219-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.