Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1240-2008

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

Diasorin Inc. / initiated 2008-02-01 / Terminated / root cause: manufacturing process

Diasorin Inc. began a recall of LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082 on . The reason FDA records is "Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1240-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Diasorin Inc.
Product
LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082
Product code
MRG System, Test, Vitamin D
Reason for recall
Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
Root cause tag
manufacturing process
FDA 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 in commerce
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.
Product codes and lots
Lot Numbers: 120422 and 120423.