Recall Z-1240-2008 ยท MRG System, Test, Vitamin D
Diasorin Inc.
LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
| Date | May 7, 2008 (initiated Feb 1, 2008) |
| Status | Terminated |
| Reason | Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032844 | LIAISON 25 OH VITAMIN D DiaSorin, Inc., Feb 12, 2004 |