Z-0788-03

AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01

Name: Z-0788-03 AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01
Creator: Abbott Laboratories, Inc
Published: 2003-02-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-02-24 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01 on 2003-02-24. The reason FDA records is "Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0788-03
Status: Terminated
Initiated: 2003-02-24
Posted: 2003-05-01
Terminated: 2004-10-28
Recalling firm: Abbott Medical
Product: AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
Root cause tag: software
FDA root cause: Other
Action: A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence.
Quantity in commerce: 645 units
Distribution: Nationwide and to the following countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand
Product codes and lots: All lots

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)