# FDA recall Z-2918-2018

> **Euro Diagnostica AB** · Class II · device recall initiated 2016-02-14.

## Product

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

## Reason for recall

Decreasing performance overtime.

## Distribution

Minnesota and Texas  Foreign: Iran

## Key facts

- **Recall number:** Z-2918-2018
- **Recalling firm:** Euro Diagnostica AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-02-14
- **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-2918-2018

## Citation

> AI Analytics. FDA recall Z-2918-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2918-2018. Source: US FDA. Licensed CC0.

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