Recall record at a glance
| Official record | Z-0815-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Lab Vision Corporation |
| Report date | Feb 24, 2016 |
| Recall initiation date | Jan 18, 2016 |
| Quantity | RB-368-R7 - 30; RB-368-R1 -2 |
| Location | Fremont, CA, United States |
Official product description
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.
Why the product was recalled
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Distribution information
Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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