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U.S. Department of Health and Human Services

Class 3 Device Recall ARCHITECT i System Assay CDROM, U.S. Version 21.0

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 Class 3 Recall
ARCHITECT i System Assay CDROM, U.S. Version 21.0
see related information
Date Posted March 08, 2007
Recall Status1 Terminated on December 09, 2009
Recall Number Z-0413-2007
Recall Event ID 37070
Premarket Approval
PMA Numbers
P050042 P050051
Product Classification Analyzer, Enzyme, For Clinical Use - Product Code JJI
Product ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21
Code Information list number 06E58-21, version 21.0, lot 45572P100
Recalling Firm/
Manufacturer
Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall
The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action On 1/2/07, Abbott sent Product Correction, Immediate Action Required letters dated 12/29/06 to all ARCHITECT AUSAB (list number 1L82-25) and ARCHITECT Anti-HCV customers (list number 1L79-25) who have the affected assay CD-ROM. The end users were informed that for the ARCHITECT AUSAB and ARCHITECT Anti-HCV assays, the default interpretations in the Assay Parameters window, installed from ARCHITECT I System Assay CD-ROM US Version 06E58-21, are not align with the result interpretation options in the package inserts. The accounts were advised to reconfigure the names of the interpretations in Assay Parameters window, following the steps in the enclosed attachments A and B. The accounts were requested to keep a copy of the letter on file until the revised Assay CD-ROM is received. 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 AUSAB and/or Anti-HCV testing, and fax it to Abbott by 1/12/07.
Quantity in Commerce 51 affected analyzers
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = JJI and Applicant = ABBOTT LABORATORIES
PMAs with Product Code = JJI and Applicant = ABBOTT LABORATORIES INC
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