FDAFDA · Food and drugs·Recall number Z-2134-2019
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-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.
Published August 7, 2019 · Recall initiated: February 21, 2018
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hycor Biomedical Inc
- Distributor
- U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India
- Lot
- Lot Number 154962
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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