Kit, Test,alpha-fetoprotein For Testicular Cancer

AFP ELISA Kit;

Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05.

The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.

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 L

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

Access Immunoassay Systems Assay Protocol: Dil-AFP.

Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.

Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, i

The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values

ST-AIA PACK AFP; Part Number: 025252

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics P

Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.