The Recall Desk

Manufacturer

Epigenomics Ag

1 recall in our database name Epigenomics Ag as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-03-28

Of the 1 recalls from Epigenomics Ag we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-1077-2018·2018-03-28

    Epigenomics Recalls Epi proColon Plasma Quick Kit Due to Invalid Test Runs

    Epigenomics Ag is recalling 200 units of the Epi proColon Plasma Quick Kit because the diagnostic test may produce invalid runs, potentially delaying results.

    Product
    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
    Category
    Medical Device
    Distribution
    10 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Epigenomics AG

biotechnology company in Berlin, Germany

Country
Germany
Founded
1998

Official website

Source: Wikidata (Q1347002), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.