Z-0846-04

AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

Name: Z-0846-04 AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Creator: Abbott Laboratories, Inc
Published: 2004-03-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-03-22 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas on 2004-03-22. The reason FDA records is "Change of level 3 error log messages to level 1 to prevent suspect assay results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0846-04
Status: Terminated
Initiated: 2004-03-22
Posted: 2004-07-20
Terminated: 2007-04-13
Recalling firm: Abbott Medical
Product: AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Change of level 3 error log messages to level 1 to prevent suspect assay results.
FDA root cause: Other
Action: The recall was initiated by letter on March 22, 2004. The letter instructed customers regarding steps to change the error levels on each AEROSET system.
Quantity in commerce: 656
Distribution: Nationwide and to the following foreign countries: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, Australia
Product codes and lots: All Serial Numbers

Product code JJE

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

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)