System, Test, Human Chorionic Gonadotropin

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Reaction vessels may contain a potential contaminant that could affect their optical performance.

Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method

Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

Free beta-hCG ELISA kit

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

Visual hCG ELISA kit

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

Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.

Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic.

Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)

Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.

Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.