Z-1142-03

Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas

Name: Z-1142-03 Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
Creator: Abbott Laboratories, Inc
Published: 2000-12-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2000-12-29 / Terminated / root cause: software

FDA source

Abbott Laboratories, Inc began a recall of Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas on 2000-12-29. The reason FDA records is "ICT assays run using a manual dilution will not be calculated correctly by the software". 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-1142-03
Status: Terminated
Initiated: 2000-12-29
Posted: 2003-08-21
Terminated: 2003-08-20
Recalling firm: Abbott Medical
Product: Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: ICT assays run using a manual dilution will not be calculated correctly by the software.
Root cause tag: software
FDA root cause: Other
Action: Product Information letter dated 29 December 2000 was sent to all AEROSET customers.
Quantity in commerce: 143
Distribution: Nationwide and to the following countries: Brazil, Canada, Australia, New Zealand, Columbia, Venezuela, Argentina, Finland, France, Germany, Greece, Hong Kong, United Kingdom, Japan, Singapore, China, Italy, Ireland, Korea, Thailand, Turkey, Norway, India
Product codes and lots: All units

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)