CDXClass II

Radioimmunoassay, Total Thyroxine

Clinical Chemistry · 21 CFR 862.1700

MDR events100All time

Recalls1All time

Registered firms14Currently listed

510(k) clearances121All time

Recent MDR events

100 adverse event reports on file

Event type breakdown

Malfunction93

Other4

Injury3

Most-reported manufacturers

Roche Diagnostics89 Roche Diagnostics4 Siemens Healthcare Diagnostics, Inc.3 Acmi Corp.1 Beckman Coulter1 Siemens Health Care Diagnostics1 Tosoh Medics1

Recalls

1 recall events for this product code

DRG International, Inc.
Open, ClassifiedAug 4, 2025
Brand Name: T4 Total ELISA
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
Z-2265-2025 · View FDA record ↗

Registered firms

14 firms currently registered for this product code

510(k) clearances

121 clearances for this product code