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 CKMB Slides: (1)VITROS CKMB Slides (60 Slide Recalled by Ortho Clinical Diagnostics Inc Due to VITROS Chemistry Products CKMB Slides Potential for Falsely...

Date: December 11, 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 CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

Quantity: Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units

Why Was This Recalled?

VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

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