Class IIOngoingZ-0788-2026
GET TESTED INTERNATIONAL AB recalls Men s Hormone Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Radioimmunoassay, Testosterones And Dihydrotestosterone recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
Class IIOngoingZ-1901-2025
Beckman Coulter, Inc. recalls Access Testosterone assay
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result i…
Beckman Coulter, Inc.MNJun 11, 2025
Class IIIOngoingZ-0805-2025
Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2.…
Qualigen IncCAJan 15, 2025