[Recalled] ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone — Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially… | FDA 2018-03-05

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Tosoh Bioscience Inc

• Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay — Class II
• Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. — Class III
• ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone — Class II
• ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic — Class II
• ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone — Class II
• ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.