Abbott Laboratories HPD/ADD/GPRD IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
list 7A24-20, lot 01687M300
Products Sold
list 7A24-20, lot 01687M300
Abbott Laboratories HPD/ADD/GPRD is recalling IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064 due to The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
Recommended Action
Per FDA guidance
Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.
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, GA, IL, KY, MA, MI, NC, OH, TN, TX, WI
Page updated: Jan 10, 2026