Recall database

Radioimmunoassay, Parathyroid Hormone recalls

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

Showing 1–2 of 2 recalls

Class IIOngoingZ-0366-2026

Siemens Healthcare Diagnostics, Inc. recalls Assay: IMMULITE 2000 Intact PTH

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the…

Parathyroid Hormone Radioimmunoassay
Under Investigation by firm

Siemens Healthcare Dia…MANov 5, 2025

Class IIOngoingZ-0803-2025

Beckman Coulter, Inc. recalls Access Intact PTH assay

Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, co…

Parathyroid Hormone Radioimmunoassay
Nonconforming Material/Component

Beckman Coulter, Inc.MNJan 15, 2025