Class III — Low Risk

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

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use Recalled by Ortho Clinical Diagnostics Inc Due to Product instability; biased ALKP values obtained from VITROS...

Date: October 16, 2020
Company: Ortho Clinical Diagnostics Inc
Status: Ongoing
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 Inc directly.

Affected Products

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Quantity: 10788 total: US 4680; OUS 6108

Why Was This Recalled?

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ortho Clinical Diagnostics Inc

Ortho Clinical Diagnostics Inc has 16 total recalls tracked by RecallDetector.

Related Recalls

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