HYTEC 288 System — Class II medical device recall Z-2200-2019
Ongoing recall by Hycor Biomedical Inc, reported 2019-08-14, distributed in TX. Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sampl
| Recall number | Z-2200-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hycor Biomedical Inc, Garden Grove, CA, United States |
| Recall initiated | 2018-03-19 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Distributed | TX |
| Countries outside the US | AT, BE, IN, IT, NL |
| Quantity | 288 |
| Model numbers | 74007P |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2200-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.