Wiener Lab CHAGATEST ELISA RECOMBINANTE V — Class II medical device recall Z-0924-2018
Ongoing recall by Wiener Laboratories, reported 2018-03-14, distributed in DC, FL, WA. Internal program testing shows that product may not reach the indicated expiration date.
| Recall number | Z-0924-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wiener Laboratories, Riobamba, N/A, Argentina |
| Recall initiated | 2017-11-10 |
| Classified | 2018-03-07 |
| Reported by FDA | 2018-03-14 |
| Distributed | DC, FL, WA |
| Countries outside the US | AR, BO, CR |
| Quantity | 1,563 units |
| Lot numbers | 1709228140 |
Product
Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
Reason for recall
Internal program testing shows that product may not reach the indicated expiration date.
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-0924-2018. 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.