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.
- Company
- Diasorin Inc.
- Recall Initiated
- May 25, 2004
- Posted
- April 13, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0704-05
- Quantity
- 70 kits
- Firm Location
- Stillwater, MN
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.
Distribution
Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel,
Lot / Code Info
catalog # CA 1725, lot # 04164
Root Cause
Other
Action Taken
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.
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