Recall Z-0922-2010
Diasorin Inc. · initiated December 16, 2009
Product
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.
Codes / lots: Lot 123127A
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.
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-0922-2010
- Initiated
- December 16, 2009
- Posted by FDA
- March 2, 2010
- Terminated
- March 29, 2012
- Product code
- LFX – Enzyme Linked Immunoabsorbent Assay, Rubella
- Quantity
- 10 kits
- Distribution
- US distribution: CA, CT, MA, MD, IL, OR
- Recalling firm
- Diasorin Inc., Stillwater, MN