Z-0843-03

Aeroset Analyzer, item 9D05-01

Name: Z-0843-03 Aeroset Analyzer, item 9D05-01
Creator: Abbott Laboratories, Inc
Published: 2001-10-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2001-10-02 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of Aeroset Analyzer, item 9D05-01 on 2001-10-02. The reason FDA records is "Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0843-03
Status: Terminated
Initiated: 2001-10-02
Posted: 2003-05-20
Terminated: 2004-04-07
Recalling firm: Abbott Medical
Product: Aeroset Analyzer, item 9D05-01
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
FDA root cause: Other
Action: The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
Quantity in commerce: 238 units
Distribution: Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England
Product codes and lots: All units on the market prior to 12/3/2001.

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)