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System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA product code PHP · Class 3 · Unknown

3
Registered devices
28
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

Epi proColon — Epigenomics AGEpi proColon — Epigenomics AGEpi proColon — Epigenomics AG

Recent recalls

DateFirmReason
2017-11-02Epigenomics AgThe diagnostic test kit may produce invalid test runs which may delay test results.
2017-04-28Exact Sciences CorporationExact 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.