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.
This recall has been terminated (originally issued March 18, 2005).
- Company
- Diasorin Inc.
- Recall Initiated
- July 15, 2004
- Posted
- March 18, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0634-05
- Quantity
- 163 Kits (lot 05144) 95 Kits (06114B)
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
Distribution
MN, MA, KY, Saudi Arabia, Jordan, Sweden, Germany, Spain, Belgium, Italy, Canada, Australia, Portugal, Hungary, Switzerland & Israel
Lot / Code Info
Catalog No. CA 1725, Lot # 05144
Root Cause
Other
Action Taken
Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.
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