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Anti-Tg AccuLite CLIA Test System - 96 Wells

MONOBIND, INC. · Model 1075-300 · UDI-DI 00816870022062

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

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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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.