Recall Z-0638-05 ยท MRG System, Test, Vitamin D
Diasorin Inc.
Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
| Date | Mar 18, 2005 (initiated Feb 14, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 31 kits |
| Distribution | MA, Spain, Germany & Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032844 | LIAISON 25 OH VITAMIN D DiaSorin, Inc., Feb 12, 2004 |