EliA dsDNA Well — Class II medical device recall Z-1107-2021
Terminated recall by Phadia US Inc, reported 2021-02-17, distributed nationwide. Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially c
| Recall number | Z-1107-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia US Inc, Portage, MI, United States |
| Recall initiated | 2020-12-14 |
| Classified | 2021-02-11 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2022-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 365 kits |
| UPC / GTIN / UDI-DI | 07333066019406 |
| Lot numbers | 0142, BFA3Y |
Product
EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
Reason for recall
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
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-1107-2021. 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.