# FDA recall Z-2922-2018

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

## Product

is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma 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-2922-2018
- **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-2922-2018

## Citation

> AI Analytics. FDA recall Z-2922-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2922-2018. Source: US FDA. Licensed CC0.

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