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

FDA device recall Z-1606-2011 · posted 2011-03-08 · Terminated

Recall details

Recalling firm

Fujirebio Diagnostics, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

OAW

Quantity affected

42 kits

Distribution

Nationwide Distribution including UT

Date initiated

2010-07-29

Date posted

2011-03-08

Date terminated

2012-07-05

Location

Malvern, PA