Reported Feb 24, 2016 · Terminated

CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description  Carcinoembryonic antigen (CEA), is…

Lab Vision Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lab Vision Corporation · 46117 Landing Pkwy · Fremont, CA · 94538-6407

Is this the product you have?

  • 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.
Lot codes and dates
  • Product CodeRB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of July 2016
  • Product code
    • RB368-R1
    • Lot Number 368R1407B
Amount recalled
RB-368-R7 - 30; RB-368-R1 -2

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 24, 2016 · Data as of Sep 19, 4:44 PM UTC

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