Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
FDA device recall Z-0638-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- 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.
- 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
- 31 kits
- Distribution
- MA, Spain, Germany & 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 |