Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

VITROS Chemistry Products CRP Slides (Reagent) Recalled by Ortho-Clinical Diagnostics Due to While performing interval testing Ortho Clinical Diagnostics (OCD)...

Date: May 9, 2013
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 Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Quantity: Domestic: 4,257; Foreign: 923

Why Was This Recalled?

While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides during the manufacturing process.

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