Recall database

System, Test, Thyroid Autoantibody recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IIOngoingZ-1009-2026

Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptav…

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

Roche Diagnostics Oper…INJan 14, 2026

Class IIOngoingZ-1844-2025

Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…

Mckesson Medical-Surgi…VAJun 4, 2025

Class IIOngoingZ-1843-2025

Mckesson Medical-Surgical Inc. Corporate Office recalls ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions.…

Mckesson Medical-Surgi…VAJun 4, 2025