Recall Z-0413-2007 ยท JJI Analyzer, Enzyme, For Clinical Use
Abbott Laboratories MPG
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
| Date | Mar 8, 2007 (initiated Jan 2, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 A |
| Quantity | 51 affected analyzers |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.