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.
FDA Recall Z-0704-05 · Posted 2005-04-13
Advertisement
Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeCIZ
Date Initiated2004-05-25
Date Terminated2006-07-22
Product Quantity70 kits
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement