FDA Device recall Z-2219-2017
Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use by Exact Sciences, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2219-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-28 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exact Sciences |
| Distribution | WI |
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.
Identifiers
| code_info | Equipment ID / Serial Number: MIX-0051 / MX00002051, MIX-0052 / MX00002032, MIX-0053 / MX00002028, MIX-0054 / M…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2219-2017%22
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