RecallDepth

LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082

Company
Diasorin Inc.
Recall Initiated
February 1, 2008
Posted
May 7, 2008
Terminated
October 31, 2008
Recall Number
Z-1240-2008
Quantity
2,267 kits
Firm Location
Stillwater, MN

Reason for Recall

Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.

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.

Lot / Code Info

Lot Numbers: 120422 and 120423.

Root Cause

Nonconforming Material/Component

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.

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