Class II — Hycor Biomedical Inc
| Recalling firm | Hycor Biomedical |
|---|---|
| Registered facility | HYCOR BIOMEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08. |
| Quantity | 288 |
| Distribution | Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India |
| Initiated | 2018-03-19 |
| Classified | 2019-08-06 |
| Recall number | Z-2200-2019 |
| 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-2200-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83268/
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