Recall Z-0922-2010 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Diasorin Inc.
DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.
| Date | Mar 2, 2010 (initiated Dec 16, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 10 kits |
| Distribution | US distribution: CA, CT, MA, MD, IL, OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY Incstar Corp., Oct 24, 1996 |