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 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Recalled by Ortho Clinical Diagnostics Due to Modifications to MicroWell Qualitative Assay Parameters Not Retained-...

Date: May 20, 2020
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 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103

Quantity: 27 ( U.S.= 0; OUS= 27)

Why Was This Recalled?

Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

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 22 total recalls tracked by RecallDetector.

Related Recalls

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