25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A.
FDA device recall Z-1237-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
- Action taken
- Consignees were notified by phone on 8/21/07 followed by a written notification by Fax or email. The letter described the product and problem and recommended to inspect the kits and to destroy all tracer vials of lot number 726023. They also requested the consignee to return the findings by fax or mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 117 kits
- Distribution
- Worldwide, including USA, CANADA, BRAZIL, INDIA, QATAR, SWEDEN, URUGUAY, ARGENTINA, and JORDAN.
- Date initiated
- 2007-08-21
- Date posted
- 2007-09-20
- Date terminated
- 2008-10-17
- 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 |
|---|---|---|
| INCSTAR 25-HYDROXYVITMIN D 1251 RIA (K953567) | Incstar Corp. | 1996-09-25 |