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 Chemistry Products Na+ Slides Recalled by Ortho-Clinical Diagnostics Due to Imprecision in the affected lot may produce negatively...

Date: January 22, 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 Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Quantity: 1448

Why Was This Recalled?

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

Where Was This Sold?

This product was distributed to 20 states: AL, CA, CT, FL, HI, ID, IL, IA, LA, MI, MS, MO, NM, NY, NC, OK, PA, TX, WV, WY

Affected (20 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