Z-1129-03

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

Name: Z-1129-03 IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2003-07-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-07-22 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064 on 2003-07-22. The reason FDA records is "The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1129-03
Status: Terminated
Initiated: 2003-07-22
Posted: 2003-08-13
Terminated: 2003-09-16
Recalling firm: Abbott Medical
Product: IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
Product code: LFX Enzyme Linked Immunoabsorbent Assay, Rubella
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 423 kits
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
Product codes and lots: list 7A24-20, lot 01687M300

Product code LFX

K931059Class IIImx Rubella Igm Antibody AssayAbbott Laboratories / cleared 1994-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)