DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.
FDA device recall Z-0634-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CIZ
- Quantity affected
- 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
- Date initiated
- 2004-07-15
- Date posted
- 2005-03-18
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 |