Recall Z-0704-05 ยท CIZ Radioimmunoassay, Androstenedione
Diasorin Inc.
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.
| Date | Apr 13, 2005 (initiated May 25, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 | 70 kits |
| Distribution | Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) Diagnostic Systems Laboratories, Inc., Dec 13, 1985 |