Z-1341-04

ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems...

Name: Z-1341-04 ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems...
Creator: Abbott Laboratories, Inc
Published: 2004-06-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-06-10 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories, Inc began a recall of ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott... on 2004-06-10. The reason FDA records is "Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1341-04
Status: Terminated
Initiated: 2004-06-10
Posted: 2004-08-13
Terminated: 2004-11-19
Recalling firm: Abbott Medical
Product: ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative.
Quantity in commerce: 171 units and 25 spare parts distributed
Distribution: Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore.
Product codes and lots: Serial numbers C800174 through C800346 and the following Serial numbers: C800072, C800122, C800131, and C800142

Product code CGZ

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)