Class III — Low Risk

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

CEA / CD66e Ab-2 Recalled by Lab Vision Corporation Due to Certain lots of CEA/CD66e Ab2 were produced with...

Date: January 18, 2016
Company: Lab Vision Corporation
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 Lab Vision Corporation directly.

Affected Products

CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description  Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). This product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.

Quantity: RB-368-R7 - 30; RB-368-R1 -2

Why Was This Recalled?

Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.

Where Was This Sold?

This product was distributed to 9 states: AZ, CA, GA, KY, MA, MS, NY, PA, TX

Affected (9 states)Not affected

About Lab Vision Corporation

Lab Vision Corporation has 3 total recalls tracked by RecallDetector.

Related Recalls

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