Recall Z-0299-2008

Reason for recall

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

FDA-determined cause: Software design

Action taken

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 informed that current AFP file has been updated on a new ARCHITECT I Assay CD-ROM (LN 6E59, version 24). The Low-Linearity flag threshold for the Amino 1:50 dilution has changed from 15 ng/mL to 20 ng/mL for consistency with overall assay sensitivity. The accounts were advised to install the updated version of the current ARCHITECT AFP assay when they receive the version 24 ARCHITECT I Assay CD-ROM. The accounts were requested to keep a copy of the letter on file. 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 testing, and fax it to Abbott by 9/28/07 at 1-800-777-0051.