# FDA recall Z-1907-2019

> **Phadia Ab** · Class II · device recall initiated 2019-05-10.

## Product

EliA RF IgM Well, REF 14-5600-01    Product Usage:  Usage:  EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000.

## Reason for recall

Potential for reporting low assay results

## Distribution

US Nationwide n the states of NJ, NY, MI, WV, TX  including  PR

## Key facts

- **Recall number:** Z-1907-2019
- **Recalling firm:** Phadia Ab
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-10
- **Report date:** 2019-07-10
- **Termination date:** 2020-06-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Uppsala, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1907-2019

## Citation

> AI Analytics. FDA recall Z-1907-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1907-2019. Source: US FDA. Licensed CC0.

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