FDA Medical Device Recalls (openFDA)
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 number
- Z-0634-05
- Recalling firm
- Diasorin Inc.
- 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.
- Status
- Terminated
- Initiated
- 2004-07-15
- Posted
- 2005-03-18
- Terminated
- 2006-07-22
- Reason
- Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
- Root cause
- Other
- 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.
- Quantity
- 163 Kits (lot 05144) 95 Kits (06114B)
- Distribution
- MN, MA, KY, Saudi Arabia, Jordan, Sweden, Germany, Spain, Belgium, Italy, Canada, Australia, Portugal, Hungary, Switzerland & Israel
- Lot, serial or model codes
- Catalog No. CA 1725, Lot # 05144
- 510(k) numbers
- ["K854650"]
- PMA numbers
- not on file
- Product code
- CIZ
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28