# FDA recall Z-2919-2018

> **Euro Diagnostica AB** · Class III · device recall initiated 2016-10-21.

## Product

is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sj¿gren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.

## Reason for recall

Incorrectly labeled  Manufactured by DiaSorin,  The correct term should be Distributed by DiaSorin.

## Distribution

MN

## Key facts

- **Recall number:** Z-2919-2018
- **Recalling firm:** Euro Diagnostica AB
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-10-21
- **Report date:** 2018-08-29
- **Termination date:** 2019-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malmo, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2919-2018

## Citation

> AI Analytics. FDA recall Z-2919-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2919-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*