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 XT 7600 Integrated System Recalled by Ortho-Clinical Diagnostics Due to Potential for sample fluid to be dispensed to...

Date: March 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 XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

Quantity: 85 units: US=19;OUS=66

Why Was This Recalled?

Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported

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