Class II — TERRAGENE S.A.
| Recalling firm | Terragene SA |
|---|---|
| Registered facility | TERRAGENE SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
| Product | Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C) |
| Quantity | 36,857 strips |
| Distribution | U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA. |
| Initiated | 2023-12-07 |
| Classified | 2024-01-26 |
| Recall number | Z-0836-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TERRAGENE S.A. (Z-0836-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93625/
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