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AccuDiag ™
Diagnostic Automation, Inc. · Model DACD-2550-1 · UDI-DI 00894175000336
10
510(k) clearances
518
Adverse events
15
Recalls
55
Facilities
Description
AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) The Diagnostic Automation Rheumatoid Factor (RF) Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection of IgM antibodies in human serum to RF antigen and as an aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use. High complexity test.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-06 | The Binding Site Group, Ltd. | It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnor |
| 2019-10-07 | The Binding Site Group, Ltd. | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to |
| 2019-08-09 | Randox Laboratories Ltd. | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjus |
| 2019-05-10 | Phadia Ab | Potential for reporting low assay results |
| 2018-03-19 | Hycor Biomedical Inc | Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out |
| 2018-02-21 | Hycor Biomedical Inc | Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor. |
| 2018-02-13 | Stanbio Laboratory, LP | All patient serum samples yield a weakly positive test result. |
| 2018-01-04 | The Binding Site Group, Ltd. | The low and high controls for the product are returning results above the assigned values. |
| 2012-03-29 | Thera Test Laboratories, Inc. | The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA |
| 2012-01-27 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.