Z-0008-06

ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00

Name: Z-0008-06 ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00
Creator: Abbott Laboratories, Inc
Published: 2005-02-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-02-28 / Terminated

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00 on 2005-02-28. The reason FDA records is "Device has incorrect notation associated with therapeutic drug monitoring assays". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0008-06
Status: Terminated
Initiated: 2005-02-28
Posted: 2005-10-06
Terminated: 2005-11-03
Recalling firm: Abbott Medical
Product: ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Device has incorrect notation associated with therapeutic drug monitoring assays.
FDA root cause: Other
Action: Firm sent device correction letters to consignees on 2/28/2005.
Quantity in commerce: 1,107 units worldwide
Distribution: California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand
Product codes and lots: List number 08G98-07 for Conventional Units; List number 04J62-07 for SI 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)