Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as Recalled by Leica Microsystems, Inc. Due to Bond Ready to Use Primary Antibody Thyroglobulin does...

Date: April 18, 2014
Company: Leica Microsystems, Inc.
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 Leica Microsystems, Inc. directly.

Affected Products

Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Quantity: 180 units

Why Was This Recalled?

Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.

Where Was This Sold?

This product was distributed to 29 states: AZ, AR, CA, CO, CT, FL, GA, IL, KY, LA, MD, MA, MI, MN, MO, MT, NH, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI

Affected (29 states)Not affected

About Leica Microsystems, Inc.

Leica Microsystems, Inc. has 40 total recalls tracked by RecallDetector.

Related Recalls

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