FDA Device recall Z-2200-2019
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument
- FDA Device
- Class II
- ongoing
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument by Hycor Biomedical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2200-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-03-19 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hycor Biomedical |
| Distribution | TX |
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
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.
Identifiers
| code_info | All lots of RF assay |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2200-2019%22
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