LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.
FDA device recall Z-0637-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 131
- Distribution
- MI, NJ, Germany, Spain and Belgium
- Date initiated
- 2005-02-14
- Date posted
- 2005-03-18
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIAISON 25 OH VITAMIN D (K032844) | DiaSorin, Inc. | 2004-02-12 |