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Autostat II Anti-Thyroglobulin

HYCOR BIOMEDICAL LLC · Model FGA03 · UDI-DI 00816879020038

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

Description

96 well ELISA for the detection of Thyroglobulin antibodies in human serum

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.