Reported Aug 14, 2019 · Ongoing
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC…
Hycor Biomedical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hycor Biomedical Inc · 7272 Chapman Ave · Garden Grove, CA · 92841-2103
Is this the product you have?
- HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only
- HYTEC AUTOSTAT II RF assaysHYTEC
- AUTOSTAT II RF IgM KitPart Number FGA 05
- HYTEC AUTOSTAT II RF IgA KitPart Number FGA 06
- HYTEC AUTOSTAT II RF IgG KitPart Number FGA 07, HYTEC
- AUTOSTAT II Total Rheumatoid Factor KitPart Number FGA 08
- Lot codes and dates
- All lots of RF assay
- Amount recalled
- 288
Where it was sold
Why it was recalled
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 of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
This product could cause temporary or reversible health problems — stop using it.
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