Diasorin Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
Catalog No. CA 1725, Lot # 05144
Products Sold
Catalog No. CA 1725, Lot # 05144
Diasorin Inc. is recalling DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnes due to Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
Recommended Action
Per FDA guidance
Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
KY, MA, MN
Page updated: Jan 10, 2026