LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.
- Company
- Diasorin Inc.
- Recall Initiated
- February 14, 2005
- Posted
- March 18, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0637-05
- Quantity
- 131
- Firm Location
- Stillwater, MN
Reason for Recall
Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.
Distribution
MI, NJ, Germany, Spain and Belgium
Lot / Code Info
catalog no. 310900, lot 114439E
Root Cause
Other
Action Taken
DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed.
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