ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and

FDA device recall Z-2239-2008 · posted 2008-09-19 · Terminated

Recall details

Recalling firm

Abbott Laboratories

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

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

Date initiated

2008-06-16

Date posted

2008-09-19

Date terminated

2010-03-18

Location

Abbott Park, IL