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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
Lot 123127A
Products Sold
Lot 123127A
Diasorin Inc. is recalling DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, S due to DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product lab. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, IL, MD, MA, OR
Page updated: Jan 10, 2026