DIASTAT anti-Nuclear antibody — Class II medical device recall Z-0929-2018
Terminated recall by Euro Diagnostica AB, reported 2018-03-14, distributed nationwide. Complaint investigation concluded that although product quality requirements stated in the instructions for us
| Recall number | Z-0929-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Euro Diagnostica AB, Malmo, N/A, Sweden |
| Recall initiated | 2015-10-15 |
| Classified | 2018-03-08 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,090 |
| UPC / GTIN / UDI-DI | 07340058410486 |
| Lot numbers | 1500, 2009 |
| Model numbers | FANA200 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0929-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.