Recall Z-0299-2008 ยท LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Abbott Laboratories
ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
| Date | Jan 9, 2008 (initiated Sep 18, 2007) |
| Status | Terminated |
| Reason | The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL |
| Root cause | Software design |
| Action | Abbott affiliates were e-mailed copies of the Product Correction (Immediate Action Required) Recall Letter on 9/18/07 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 18 September 2007 to all active non-U.S. ARCHITECT customers who have the affected assay CD-ROMs. The end users were inform |
| Quantity | 2,490 |
| Distribution | International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Thailand, Uruguay and Venezuela. There were no USA accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.