Recall Z-0637-05 ยท MRG System, Test, Vitamin D
Diasorin Inc.
LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.
| Date | Mar 18, 2005 (initiated Feb 14, 2005) |
| Status | Terminated |
| Reason | 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. |
| 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 | 131 |
| Distribution | MI, NJ, Germany, Spain and 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 |