DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in seru
FDA device recall Z-0704-05 · posted 2005-04-13 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CIZ
- Quantity affected
- 70 kits
- Distribution
- Massachusetts, Saudi Arabia, Sweden, Germany, Spain, Belgium, Italy, Camada. Australia, Portugal, Hungary, Israel,
- Date initiated
- 2004-05-25
- Date posted
- 2005-04-13
- 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 |