Z-0781-04

ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories...

Name: Z-0781-04 ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2004-03-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-03-23 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A on 2004-03-23. The reason FDA records is "The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0781-04
Status: Terminated
Initiated: 2004-03-23
Posted: 2004-07-20
Terminated: 2005-04-26
Recalling firm: Abbott Medical
Product: ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Reason for recall: The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
FDA root cause: Other
Action: Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.
Quantity in commerce: 1,987 kits
Distribution: Canada, Australia, Germany and Japan
Product codes and lots: lot numbers 07747M100 and 07747M101

Product code NIG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)