Z-2239-2008

ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list...

Name: Z-2239-2008 ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list...
Creator: Abbott Laboratories
Published: 2008-06-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-06-16 / Terminated / root cause: software

FDA source

Abbott Laboratories began a recall of ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to... on 2008-06-16. The reason FDA records is "When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2239-2008
Status: Terminated
Initiated: 2008-06-16
Posted: 2008-09-19
Terminated: 2010-03-18
Recalling firm: Abbott Medical
Product: ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops running. No results are generated.
Root cause tag: software
FDA root cause: Software design
Action: Abbott affiliates were e-mailed copies of the recall letter Urgent Field Safety Notice Product Correction on 6/16/08 for translation where needed and dissemination to their ARCHITECT accounts who have the affected assay CD-ROMs. Each Abbott international organization will be responsible for contacting customers and determining the method of effectiveness checks based on their country requirements. Abbott sent Product Correction, Immediate Action Required letters dated June 16, 2008 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were informed when running the Automated Dilution Protocol of the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System, software error code [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops. The accounts were advised to not use the Automated Dilution Protocol of either the ARCHITECT CMV IgG and Toxo IgG assays on the ARCHITECT i1000SR System and report results for samples requiring dilution as ">250.0 AU/mL" for CMV IgG and ">200.0 IU/mL" for Toxo IgG until a corrected version of the ARCHITECT i1000SR System Assay CD-ROM is available in late September 2008. The accounts were requested to keep a copy of the letter on file. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect testing, and fax it to Abbott by 7/1/08 at 1-800-777-0051. If you have question, contact your local area Customer Support.
Quantity in commerce: 75 CD-ROMs
Distribution: Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, India, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Sweden, Saudi Arabia, Spain, United Arab Emirates
Product codes and lots: List 01P61, Special edition Version 1.01 and Version 2.0, Assay CD-ROM lot number 63062P100

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)