Z-0721-03

AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number...

Name: Z-0721-03 AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number...
Creator: Abbott Laboratories, Inc
Published: 2002-12-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-12-12 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories on 2002-12-12. The reason FDA records is "The autoprint feature allows the switch of patient IDs in remote cases". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0721-03
Status: Terminated
Initiated: 2002-12-12
Posted: 2003-04-15
Terminated: 2004-10-28
Recalling firm: Abbott Medical
Product: AEROSET System Software version 1.00ER005 Catalog Number 2-89996-01 and 1.00ER005.2 Catalog Number 2-89996-02, distributed by Abbott Laboratories
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The autoprint feature allows the switch of patient IDs in remote cases.
FDA root cause: Other
Action: The firm sent a Device Correction letter to all consignees on 12/12/2002, requesting that the users make adjustments to their systems, and retain the letter in their user manual. The letter included a customer reply form. The software will be corrected with the release of the next version.
Quantity in commerce: 640
Distribution: Nationwide and to the following foreign countries: Mexico, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zeland
Product codes and lots: Version 1.00ER005 Catalog Number 2-89996-01 and Version 1.00ER005.2 Catalog Number 2-89996-02 AEROSET System software is not controlled by Control or Lot numbers.

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)