Z-0725-03

AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02

Name: Z-0725-03 AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02
Creator: Abbott Laboratories, Inc
Published: 2003-02-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-02-24 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02 on 2003-02-24. The reason FDA records is "Under certain operating conditions, smart wash feature disables with multiple samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0725-03
Status: Terminated
Initiated: 2003-02-24
Posted: 2003-04-16
Terminated: 2004-10-28
Recalling firm: Abbott Medical
Product: AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Under certain operating conditions, smart wash feature disables with multiple samples.
FDA root cause: Other
Action: A device correction letter was sent 02/24/2003 to all AEROSET customers with a US Customer Reply Form. A Technical Service Bulletin will be released to include the Device Correction letter and instructions for Field Service Personnel. A Quality Directive will be issued to provide instructions to Customer Service.
Quantity in commerce: 645 units
Distribution: Nationwide and to Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, and New Zeland
Product codes and lots: No codes: Catalog numbers 2-89996-01 and 2-89996-02

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)