Z-0815-2016Class III

CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA)...

Name: Z-0815-2016 CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description Carcinoembryonic antigen (CEA)...
Creator: Lab Vision Corporation
Published: 2016-01-18
License: https://open.fda.gov/license/

Lab Vision Corp. / initiated 2016-01-18 / Terminated / root cause: manufacturing process

FDA source

Lab Vision Corporation began a recall of 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... on 2016-01-18. FDA classified it as Class III and gives the reason as "Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0815-2016
Classification: Class III
Status: Terminated
Initiated: 2016-01-18
Posted: 2016-02-17
Terminated: 2016-06-24
Recalling firm: Lab Vision Corp.
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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0815-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0815-2016	Class III	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-17

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)