Terragene Bionova PCD — Class II medical device recall Z-0837-2024
Ongoing recall by TERRAGENE S.A., reported 2024-02-07, distributed nationwide. Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the
| Recall number | Z-0837-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TERRAGENE S.A., Alvear, Argentina |
| Recall initiated | 2023-12-07 |
| Classified | 2024-01-26 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 80 stripes |
| UPC / GTIN / UDI-DI | 07798164676027 |
| Serial numbers | F20002, F20021, F20046 |
Product
Terragene Bionova PCD (PCD222-C)
Reason for recall
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
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-0837-2024. 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.