Class III — Lab Vision Corporation
| Recalling firm | Vision Lab Co, LLC |
|---|---|
| Registered facility | VISION LAB CO, LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250. |
| 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-embed… |
| 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. |
| Initiated | 2016-01-18 |
| Classified | 2016-02-17 |
| Terminated | 2016-06-24 |
| Recall number | Z-0815-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Lab Vision Corporation (Z-0815-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73120/
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