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PRE WSH Kit
EXACT SCIENCES CORPORATION · Model 100319 · UDI-DI 00858637005604
PHP
Prescription
0
510(k) clearances
32
Adverse events (1 deaths)
2
Recalls
12
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-02 | Epigenomics Ag | The diagnostic test kit may produce invalid test runs which may delay test results. |
| 2017-04-28 | Exact Sciences Corporation | 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 th |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.