DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabol
FDA device recall Z-0705-05 · posted 2005-04-13 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
- Action taken
- A customer notification letter was sent to customers 6/30/04. The letter identified theproduct, problem and the correct expiration date. Customers were instructed to complete the response form on the lower portion of the notification and fax it back to DiaSorin.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCI
- Quantity affected
- 181
- Distribution
- MI, IL, AZ, MN, OR, GA, MO, Sweden, Germany, Great Britain, Spain, Belgium, Italy, Norway, Brazil, Hungary, Switzerland
- Date initiated
- 2004-06-30
- 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 |
|---|---|---|
| 25-HYDROXYVITAMIN D 125I RIA KIT (K983617) | DiaSorin, Inc. | 1998-11-16 |