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 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.

Recall number

Z-0815-2016

Recalling firm

Lab Vision Corporation

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.

Status

Terminated

Initiated

2016-01-18

Posted

2016-02-17

Terminated

2016-06-24

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 result was obtained. If a valid result was obtained, no further action is required. If high background staining was seen, standard IHC troubleshooting guidance for high background staining can be used. (See RISK TO HEALTH section of the letter.) Affected product may be returned to Lab Vision. Please indicate on the Acknowledgement Form whether the product will be returned. Upon receipt of the form, RGA information will be sent for product requiring return. If it is preferred to destroy the product at the customer site, please indicate this on the Acknowledgement form. Please use the attached Recall Return Response Acknowledgement & Receipt Form. Customers with questions were instructed to call 269-544-5628.

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

NJT

Firm FEI

3000719701

Firm city

Fremont

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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