Recall Z-0634-05 ยท CIZ Radioimmunoassay, Androstenedione
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.
| Date | Mar 18, 2005 (initiated Jul 15, 2004) |
| Status | Terminated |
| 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 |
| 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 |