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 Chemistry Products TBIL-ALKP Slides Recalled by Ortho-Clinical Diagnostics, INc. Due to Samples containing high levels of ALKP (or an...

Date: August 5, 2023
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 XT Chemistry Products TBIL-ALKP Slides

Quantity: 52,456 units

Why Was This Recalled?

Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

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 9 total recalls tracked by RecallDetector.

Related Recalls

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