# FDA recall Z-2134-2019

> **Hycor Biomedical Inc** · Class II · device recall initiated 2018-02-21.

## 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 assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.

## Reason for recall

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.

## Distribution

U.S.: TX.    Foreign (OUS): Netherlands, Belgium, Austria, Italy, India

## Key facts

- **Recall number:** Z-2134-2019
- **Recalling firm:** Hycor Biomedical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-02-21
- **Report date:** 2019-08-07

- **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-2134-2019

## Citation

> AI Analytics. FDA recall Z-2134-2019. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2134-2019. Source: US FDA. Licensed CC0.

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