Antinuclear Antibody, Antigen, Control

is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for t

Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA

Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.

DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories.

Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.

Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests,

The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability.

Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest I

The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.

Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc.

Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass..

Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test,

False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment .

Autoimmune EIA ANA Screening Test Kit, 96 Tests,

The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.

Autoimmune EIA ANA Screening Test Kit, 576 Tests,

The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading.

BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laborat

False negative results due to reagent packs exhibiting low signal.