Z-1606-2011

MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed...

Name: Z-1606-2011 MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed...
Creator: Fujirebio Diagnostics, Inc.
Published: 2010-07-29
License: https://open.fda.gov/license/

Fujirebio Diagnostics, Inc. / initiated 2010-07-29 / Terminated

FDA source

Fujirebio Diagnostics, Inc. began a recall of MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests... on 2010-07-29. The reason FDA records is "presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1606-2011
Status: Terminated
Initiated: 2010-07-29
Posted: 2011-03-08
Terminated: 2012-07-05
Recalling firm: Fujirebio Diagnostics, Inc.
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.
Product code: OAW Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma
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 root cause: Other
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
Product codes and lots: Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010

Product code OAW

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)