FDA Device

IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064

Hazard

The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.

What You Should Do

Remedy

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.

Products

IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD/GPRD
UPC
list 7A24-20, lot 01687M300

Units Affected

423 kits