Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ST-AIA PACK PAP Recalled by Tosoh Bioscience Inc Due to Asfotase Alfa (Strensiq) interferes with certain Tosoh assays...

Date: March 5, 2018
Company: Tosoh Bioscience Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience Inc directly.

Affected Products

ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate

Quantity: 1083

Why Was This Recalled?

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tosoh Bioscience Inc

Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report