Device 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.
Z-0815-2016
Product summary
- Event
- Event 73120
- Status
- Terminated
- Classification
- Class III
- Quantity
- RB-368-R7 - 30; RB-368-R1 -2
- Official record key
device-enforcement:Z-0815-2016
Official wording
Reason: Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Code information: Product Code: RB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of July 2016. Product code: RB368-R1, Lot Number 368R1407B.
Distribution pattern: Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
Derived failure modes
-
Unknown
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.