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 Anti-HBs Quantitative Reagent Pack Recalled by Ortho-Clinical Diagnostics, Inc. Due to Affected lots may experience increased calibration failures or...

Date: November 27, 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 Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

Quantity: 6,920 US; 57 OUS

Why Was This Recalled?

Affected lots may experience increased calibration failures or an increase in falsely elevated results.

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 62 total recalls tracked by RecallDetector.

Related Recalls

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