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QUANTA Flash RF IgM Reagents
INOVA DIAGNOSTICS, INC. · Model 701340 · UDI-DI 08426950845249
DHR
Prescription
1
510(k) clearances
518
Adverse events
15
Recalls
55
Facilities
Description
1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations: a. Rabbit pAb coated paramagnetic beads. b. Assay buffer - colored pink, containing proteing stabilizers and preservatives. c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives.
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.