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SeraQuest

QUEST INTERNATIONAL, INC. · Model Anti-TG · UDI-DI 00850487007494

DDC Prescription
10
510(k) clearances
1
Adverse events
1
Recalls
12
Facilities

Description

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)

Recalls

DateFirmReason
2006-10-26Beckman Coulter IncLow end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.