Reported Aug 7, 2019 · Completed
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be…
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?
- AUTOSTAT II IgM Rheumatoid Factor, IVD
- PartFGA 05
- Product UsageRheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure
- The Intended Use is as followsEnzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only
- Lot codes and dates
- Lot Number 154962
- Amount recalled
- 207
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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