Class II — Potential Health Hazard

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

Vitros Myoglobin Calibrators Recalled by Ortho Clinical Diagnostics Inc Due to A stability issue in the calibrators may cause...

Date: November 29, 2018
Company: Ortho Clinical Diagnostics 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 Ortho Clinical Diagnostics Inc directly.

Affected Products

Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma

Quantity: 4030

Why Was This Recalled?

A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc has 16 total recalls tracked by RecallDetector.

Related Recalls

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