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QMS Everolimus Immunoassay

Microgenics Corporation · Model 0380005 · UDI-DI 00884883000537

OUF
2
510(k) clearances
1
Adverse events
1
Recalls
2
Facilities

Recalls

DateFirmReason
2016-08-15Microgenics CorporationA reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of

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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.