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U.S. Department of Health and Human Services

Class 3 Device Recall MESOMARK

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  Class 3 Device Recall MESOMARK see related information
Date Initiated by Firm July 29, 2010
Date Posted March 08, 2011
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-1606-2011
Recall Event ID 56427
HDE Number H060004 
Product Classification Cancer monitoring test system, soluble mesothelinrelated peptides, epithelioid/biphasic mesothelioma - Product Code OAW
Product MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests.
MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
Code Information Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
Recalling Firm/
Fujirebio Diagnostics, Inc.
201 Great Valley Pkwy
Malvern PA 19355-1308
For Additional Information Contact customer service
Manufacturer Reason
for Recall
presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.
FDA Determined
Cause 2
Action Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight. FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory. Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010. Notify your ordering physician or health care provider as appropriate. For questions regarding this recall call 877-861-7246 or 610-240-3800.
Quantity in Commerce 42 kits
Distribution Nationwide Distribution including UT
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = OAW and Original Applicant = Fujirebio Diagnostics, Inc.