# FDA recall Z-0929-2018

> **Euro Diagnostica AB** · Class II · device recall initiated 2015-10-15.

## Product

DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200.    Product Usage:  The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

## Reason for recall

Complaint investigation concluded that although product quality  requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the  strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample  test results for the two FANA200 kit lots SS 1500 and SS 2009.

## Distribution

Worldwide Distribution and US. Nationwide

## Key facts

- **Recall number:** Z-0929-2018
- **Recalling firm:** Euro Diagnostica AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-10-15
- **Report date:** 2018-03-14
- **Termination date:** 2019-03-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2018

## Citation

> AI Analytics. FDA recall Z-0929-2018. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0929-2018. Source: US FDA. Licensed CC0.

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