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

FDA device recall Z-0815-2016 · posted 2016-02-17 · Terminated

Recall details

Recalling firm

Lab Vision Corporation

Reason for recall

Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NJT

Quantity affected

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.

Date initiated

2016-01-18

Date posted

2016-02-17

Date terminated

2016-06-24

Location

Fremont, CA