Class II — Hycor Biomedical Inc
| Recalling firm | Hycor Biomedical |
|---|---|
| Registered facility | HYCOR BIOMEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | 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. |
| 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 as… |
| Quantity | 207 |
| Distribution | U.S.: TX. Foreign (OUS): Netherlands, Belgium, Austria, Italy, India |
| Initiated | 2018-02-21 |
| Classified | 2019-07-30 |
| Recall number | Z-2134-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hycor Biomedical Inc (Z-2134-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82952/
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