DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-
FDA device recall Z-0922-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results.
- Action taken
- Consignees were sent a DiaSorin Customer Notification letter dated December 16, 2009. The Letter was addressed to Customer. The letter described the product and the problem and indicated a replacement product will be provided. Requested consignees to complete the acknowledgement receipt form. For questions or concerns please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LFX
- Quantity affected
- 10 kits
- Distribution
- US distribution: CA, CT, MA, MD, IL, OR
- Date initiated
- 2009-12-16
- Date posted
- 2010-03-02
- Date terminated
- 2012-03-29
- 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 |
|---|---|---|
| INCSTAR RUBELLA IGG ELISA ASSAY (K960367) | Incstar Corp. | 1996-10-24 |