FDA Device recall Z-0815-2016
CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1
- FDA Device
- Class III
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class III recall of CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1 by Lab Vision, citing certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0815-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-01-18 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Lab Vision |
| Distribution | AZ, CA, GA, KY, MA, MS, NY, PA, TX |
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
Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Identifiers
| code_info | Product Code: RB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of Ju…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2016%22
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