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Critical Diagnostics

Active in EUDAMED

United Statesfrom EUDAMED address EUDAMED SRN US-MF-000025164

Devices
0
Registrations
EUDAMED
FDA recalls
1

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

Company details

EUDAMED SRN
US-MF-000025164
EUDAMED status
Active
EUDAMED registered name
Critical Diagnostics
PRRC contact
James Snider(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2012

    • 28 Feb 2012 Z-2012-2012 Class III Terminated The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits. Distribution: USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy. Submission number: K111452