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ANA Screen ELISA Test Kit
MERIDIAN BIOSCIENCE, INC. · Model 4884261 · UDI-DI 00840733101014
LKJ
Prescription
1
510(k) clearances
23
Adverse events
13
Recalls
15
Facilities
Description
The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-01 | Bio-Rad Laboratories, Inc. | A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs. |
| 2017-05-22 | Euro Diagnostica AB | FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referen |
| 2017-02-14 | Euro Diagnostica AB | 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 |
| 2016-10-21 | Euro Diagnostica AB | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| 2015-10-15 | Euro Diagnostica AB | Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the |
| 2010-06-24 | 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 |
| 2010-03-01 | Bio-Rad Laboratories Inc | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
| 2010-03-01 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability. |
| 2010-03-01 | Bio-Rad Laboratories Inc | Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. |
| 2010-03-01 | Bio-Rad Laboratories Inc | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
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