# FDA recall Z-2200-2019

> **Hycor Biomedical Inc** · Class II · device recall initiated 2018-03-19.

## 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.

## Distribution

Worldwide distribution to US state of TX , Netherlands, Belgium, Austria, Italy, and India

## Key facts

- **Recall number:** Z-2200-2019
- **Recalling firm:** Hycor Biomedical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-03-19
- **Report date:** 2019-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Garden Grove, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2200-2019

## Citation

> MORVS. FDA recall Z-2200-2019. Retrieved 2026-11-04 from https://api.morvs.ai/recall/Z-2200-2019. Source: US FDA. Licensed CC0.

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