Class III — Low Risk

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

VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface Recalled by Ortho-Clinical Diagnostics Due to Ortho Clinical Diagnostics is recalling certain lots of...

Date: November 1, 2012
Company: Ortho-Clinical Diagnostics
Status: Terminated
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 Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.

Quantity: 1464 units

Why Was This Recalled?

Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.

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 185 total recalls tracked by RecallDetector.

Related Recalls

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