Z-0815-2016 Class III Terminated
FDA device recall Z-0815-2016 was initiated by Lab Vision Corporation on January 18, 2016 and is designated Class III. Reason for recall: Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250. The recall status is terminated (terminated June 24, 2016). Affected quantity: RB-368-R7 - 30; RB-368-R1 -2.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2016
- Initiation Date
- January 18, 2016
- Termination Date
- June 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- RB-368-R7 - 30; RB-368-R1 -2
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.
Reason for Recall
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Distribution Pattern
Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
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.