AUTOSTAT II IgM Rheumatoid Factor — Class II medical device recall Z-2134-2019
Completed recall by Hycor Biomedical Inc, reported 2019-08-07, distributed in TX. Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples ma
| Recall number | Z-2134-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hycor Biomedical Inc, Garden Grove, CA, United States |
| Recall initiated | 2018-02-21 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Distributed | TX |
| Countries outside the US | AT, BE, IN, IT, NL |
| Quantity | 207 |
| Lot numbers | 154962 |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.