Diasorin Inc. Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
manufacturer part # 310900, Lot #114668
Products Sold
manufacturer part # 310900, Lot #114668
Diasorin Inc. is recalling Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 due to An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RL. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA
Page updated: Jan 10, 2026