Z-0091-04

AEROSET System Software version 1.02ER000

Name: Z-0091-04 AEROSET System Software version 1.02ER000
Creator: Abbott Laboratories, Inc
Published: 2003-09-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-09-30 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of AEROSET System Software version 1.02ER000 on 2003-09-30. The reason FDA records is "Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0091-04
Status: Terminated
Initiated: 2003-09-30
Posted: 2004-07-20
Terminated: 2004-04-07
Recalling firm: Abbott Medical
Product: AEROSET System Software version 1.02ER000
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
FDA root cause: Other
Action: The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.
Quantity in commerce: 133
Distribution: Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China
Product codes and lots: Catalog 2-95068-01 AEROSET System Software 1.02ER000 and Catalog 2-95175-01 AEROSET System Software 1.02ER000 Upgrade Kit

Product code JQP

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)