| Class 3 Device Recall ARCHITECT i System Assay CDROM, U.S. Version 21.0 | |
Date Initiated by Firm | January 02, 2007 |
Date Posted | March 08, 2007 |
Recall Status1 |
Terminated 3 on December 09, 2009 |
Recall Number | Z-0413-2007 |
Recall Event ID |
37070 |
PMA Number | P050051 P050042 |
Product Classification |
in vitro diagnostic analyzer - Product Code JJI
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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 IL 60064-3502
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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 | Other |
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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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