Z-0704-05

DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione...

Name: Z-0704-05 DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione...
Creator: Diasorin Inc.
Published: 2004-05-25
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2004-05-25 / Terminated

FDA source

Diasorin Inc. began a recall of DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164... on 2004-05-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0704-05
Status: Terminated
Initiated: 2004-05-25
Posted: 2005-04-13
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
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.
Product code: CIZ Radioimmunoassay, Androstenedione
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 70 kits
Distribution: Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel,
Product codes and lots: catalog # CA 1725, lot # 04164

Product code CIZ

K854650Class IDsl Active Androstenedione Ria (Dsl #3800)Diagnostic Systems Laboratories, Inc. / cleared 1985-12-13

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)