Diasorin Inc. DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
catalog # CA 1725, lot # 04164
Products Sold
catalog # CA 1725, lot # 04164
Diasorin Inc. is recalling DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstene due to Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
Recommended Action
Per FDA guidance
Customers were sent notification letters informing them of the product and problem and recommended the destruction of any remaining inventory. Letter also requested the completion and return of the lower portion of the letter.
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
MA
Page updated: Jan 10, 2026