Recall Z-0815-2016 ยท NJT Immunohistochemistry Reagents And Kits
Lab Vision Corporation
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 adenocarcino
| Date | Feb 17, 2016 (initiated Jan 18, 2016) |
| Status | Terminated |
| Reason | Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250. |
| Root cause | Nonconforming Material/Component |
| Action | ThermoFisher sent an Urgent Medical Device recall letter dated January 18, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have any of the affected product to contact Lab Vision with the information requested on the attached Acknowledgment Form. Upon identification of the affected lot, please notify Lab Vision of the quantity previously used and the quantity still in inventory. If any of the above listed lots were previously used, please review test results to ensure a valid resul |
| Quantity | RB-368-R7 - 30; RB-368-R1 -2 |
| Distribution | Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.