CEA / CD66e Ab-2 — Class III medical device recall Z-0815-2016
Terminated recall by Lab Vision Corporation, reported 2016-02-24, distributed in AZ, CA, GA, KY, MA, MS, NY, PA…. Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
| Recall number | Z-0815-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lab Vision Corporation, Fremont, CA, United States |
| Recall initiated | 2016-01-18 |
| Classified | 2016-02-17 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2016-06-24 |
| Distributed | AZ, CA, GA, KY, MA, MS, NY, PA, TX |
| Countries outside the US | DE, FR, GR, RS, SG |
| Lot numbers | 368R1407A, 368R1407B, 368R1407C, 368R1407D, 368R1407E |
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.
Reason for recall
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0815-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.