IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
- Company
- Abbott Laboratories Hpd/Add/Gprd
- Recall Initiated
- July 22, 2003
- Posted
- August 13, 2003
- Terminated
- September 16, 2003
- Recall Number
- Z-1129-03
- Quantity
- 423 kits
- Firm Location
- Abbott Park, IL
Reason for Recall
The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
Distribution
California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras
Lot / Code Info
list 7A24-20, lot 01687M300
Root Cause
Other
Action Taken
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.