Recall Z-0384-06 ยท DFT Igm, Antigen, Antiserum, Control
Abbott Laboratories Diagnostic Div
Clinical Chemistry Immunoglobulin M, List Number 1E01-20
| Date | Jan 11, 2006 (initiated Nov 10, 2005) |
| Status | Terminated |
| Reason | These specific protein assays are not meeting the 57-day on board stability claim |
| Root cause | Other |
| Action | A Device Correction letter identifying the changes being made to the frequency of QC monitoring for these assays, will be distributed to all AEROSET and ARCHITECT c8000 customers which utilize the IgM, Prealbumin and Apolipoprotein Al Specifc Protein assays on November 10,2005 via direct mailing. Outside the U.S. each country organization will need to determine the appropriate method for the effectiveness check.. |
| Quantity | 1275 (212 in US) |
| Distribution | Nationwide, plus Australia, Canada, Columbia, Germany, Guatemala, Hong Kong, mexico, & New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983132 | IGM Abbott Laboratories, Nov 4, 1998 |