Home › Device types › DHR
System, Test, Rheumatoid Factor
FDA product code DHR · Class 2 · Immunology
116
Registered devices
518
Adverse events
15
Recalls
144
510(k) clearances
Devices with this code
RF Control Set — Roche Diagnostics GmbHRF LATEX Test Kit — CENOGENICS CORPORATIONDetector Lex RA — Immunostics Company, IncDiamedix — DIAMEDIX CORPORATIONQUANTA Lite® RF IgG ELISA — INOVA DIAGNOSTICS, INC.Rheumajet RF 50 TESTS — BIOKIT, S.A.RHEUMATEX® — ALERE NORTH AMERICA, LLCIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA IgM Conjugate 200 — Phadia ABRheumatoid Factor IgM ELISA — DRG International IncIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA RF IgA Well — Phadia ABCAROLINA LIQUID CHEMISTRIES CORP.® RF REAGENT CC629 — CAROLINA LIQUID CHEMISTRIES CORPORATIONK-ASSAY® RF Reagent (Ver.2) — KAMIYA BIOMEDICAL COMPANY, LLCSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.EliA RF IgM Well — Phadia ABIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.RHEUMATOID FACTOR TOTAL — ORGENTEC Diagnostika GmbHRF — RANDOX LABORATORIES LIMITEDASI RF Direct Slide Test — ARLINGTON SCIENTIFIC, INC.Autostat II IgG Rheumatoid Factor — HYCOR BIOMEDICAL LLCPulse Scientific Inc. — Pulse Scientific IncSure-Vue — FISHER SCIENTIFIC COMPANY L.L.C.
Recent 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 rep |
| 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 |
| 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 va |
| 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 co |
| 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 Rh |
| 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 |
| 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 sa |
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