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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00776-1
Product Name/Description Cell Marque CDX-2 (EPR2864Y*) antibody 7ml - an in vitro diagnostic medical device (IVD)

Catalogue Numbers: CM235R-17 and CM235R-18

Lot Number: 1221903
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/07/2013
Responsible Entity Abacus ALS Pty Ltd
Reason/Issue Cell Marque CDX-2 is used to aid in the differentiation of colorectal adenocarcinoma and lung adenocarcinomas. The CDX-2 antibody typically stains the nuclei of colorectal carcinoma cells but not lung adenocarcinoma cells. Abacus has advised that the CDX-2 antibody may exhibit a light sporadic, focal, nuclear staining in a limited number of lung adenocarcinomas such as those with enteric differentiation, and may demonstrate slightly stronger staining than other lots.
Recall Action Recall
Recall Action Instructions Abacus ALS is requesting users to destroy affected stock. Replacement units will be provided as soon as possible. The requirement for a review of patient results reported from this lot should be determined by the laboratory director.
Contact Information 1800 287 287 - Abacus ALS Customer Service