Class III — Low Risk

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

D2-40 (Lymphatic Marker) Recalled by Biocare Medical, LLC Due to Firm discovered that incorrect Instructions for Use were...

Date: May 6, 2015
Company: Biocare Medical, LLC
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 Biocare Medical, LLC directly.

Affected Products

D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.

Quantity: 19 units

Why Was This Recalled?

Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Biocare Medical, LLC

Biocare Medical, LLC has 9 total recalls tracked by RecallDetector.

Related Recalls

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