Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
- Company
- Diasorin Inc.
- Recall Initiated
- February 14, 2005
- Posted
- March 18, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0638-05
- Quantity
- 31 kits
- Firm Location
- Stillwater, MN
Reason for Recall
An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data.
Distribution
MA, Spain, Germany & Belgium
Lot / Code Info
manufacturer part # 310900, Lot #114668
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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