FDA Medical Device Recalls (openFDA)
Abbott Laboratories: 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.
- Recall number
- Z-2239-2008
- Recalling firm
- Abbott Laboratories
- 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.
- Status
- Terminated
- Initiated
- 2008-06-16
- Posted
- 2008-09-19
- Terminated
- 2010-03-18
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- List 01P61, Special edition Version 1.01 and Version 2.0, Assay CD-ROM lot number 63062P100
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28