Class II — Potential Health Hazard

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

QMS Tacrolimus Calibrators Recalled by Ortho-Clinical Diagnostics, Inc. Due to Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators,...

Date: November 21, 2023
Company: Ortho-Clinical Diagnostics, Inc.
Status: Ongoing
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 Ortho-Clinical Diagnostics, Inc. directly.

Affected Products

QMS Tacrolimus Calibrators, Product code 10015573

Quantity: 10 sales units US; 1 sales unit OUS

Why Was This Recalled?

Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the affected lot may results in erroneous calibration results, causing delay in testing.

Where Was This Sold?

This product was distributed to 6 states: FL, IL, IN, NJ, NM, TX

Affected (6 states)Not affected

About Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.

Related Recalls

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