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.
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