# FDA recall Z-2920-2018

> **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 IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders

## Reason for recall

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

## Distribution

MN

## Key facts

- **Recall number:** Z-2920-2018
- **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-2920-2018

## Citation

> AI Analytics. FDA recall Z-2920-2018. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2920-2018. Source: US FDA. Licensed CC0.

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