LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
FDA device recall Z-1240-2008 · posted 2008-05-07 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
- Action taken
- Consignees were notified by a Diasorn Customer Notification Letter sent by email on 2/1/08. The letter instructs users to stop using the affected kits, destroy any kits remaining in inventory and to return a response form in order to receive replacement product. For additional information contact 1-800-328-1482.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 2,267 kits
- Distribution
- Worldwide Distribution including USA states of AR, CA, GA, IA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OR, PA, TN, UT and WA and country of Austria.
- Date initiated
- 2008-02-01
- Date posted
- 2008-05-07
- Date terminated
- 2008-10-31
- 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 |
|---|---|---|
| LIAISON 25 OH VITAMIN D (K032844) | DiaSorin, Inc. | 2004-02-12 |