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.
This recall has been terminated (originally issued March 2, 2010).
- Company
- Diasorin Inc.
- Recall Initiated
- December 16, 2009
- Posted
- March 2, 2010
- Terminated
- March 29, 2012
- Recall Number
- Z-0922-2010
- Quantity
- 10 kits
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US distribution: CA, CT, MA, MD, IL, OR
Lot / Code Info
Lot 123127A
Root 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.