Recall Z-0815-2016— Lab Vision Corporation

Class III FDA medical device recall by Lab Vision Corporation, initiated 2016-01-18, terminated 2016-06-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250..

Recalling firm

Lab Vision Corporation

Classification

Class III

Status

Terminated

Initiated

2016-01-18

Terminated

2016-06-24

Firm location

Fremont, CA, United States

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