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 Immunodiagnostic Products Troponin I ES Reagent Pack Recalled by ORTHO-CLINICAL DIAGNOSTICS Due to Reagent packs could potentially contain incorrect wells, which...

Date: June 5, 2023
Company: ORTHO-CLINICAL DIAGNOSTICS
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 directly.

Affected Products

VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

Quantity: 4,013 units

Why Was This Recalled?

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

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 14 total recalls tracked by RecallDetector.

Related Recalls

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