DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels in serum.
FDA Recall Z-0634-05 · Posted 2005-03-18
Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeCIZ
Date Initiated2004-07-15
Date Terminated2006-07-22
Product Quantity163 Kits (lot 05144) 95 Kits (06114B)
Reason for Recall
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
Firm Action
Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.
Root Cause
Other
Distribution Pattern
MN, MA, KY, Saudi Arabia, Jordan, Sweden, Germany, Spain, Belgium, Italy, Canada, Australia, Portugal, Hungary, Switzerland & Israel
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.