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Simplexa™ C. difficile Universal Direct

DIASORIN MOLECULAR LLC · Model MOL2975 · UDI-DI 20816101025583

OMN Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
5
Facilities

Recalls

DateFirmReason
2025-10-07Meridian Bioscience IncThe cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
2014-04-22Meridian Bioscience IncIllumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

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Data 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.