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¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: Recalled by Ortho-Clinical Diagnostics Due to Luminometer Malfunction May Cause Inability to Process MicroWell...

Date: February 20, 2019
Company: Ortho-Clinical Diagnostics
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 directly.

Affected Products

VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Quantity: 4 units

Why Was This Recalled?

Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics has 185 total recalls tracked by RecallDetector.

Related Recalls

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