Class II — Potential Health Hazard

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

DiaSorin Recalled by Diasorin Inc. Due to Instability in the PRO-Trac II Tacrolimus ELISA kit...

Date: March 16, 2015
Company: Diasorin 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 Diasorin Inc. directly.

Affected Products

DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.

Quantity: 451 kits

Why Was This Recalled?

Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Diasorin Inc.

Diasorin Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

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