Brand
TERRAGENE S.A.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for TERRAGENE S.A. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-05FDA-DeviceClass IIASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
- 2024-02-07FDA-DeviceClass IITerragene Bionova PCD (PCD222-C)
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
- 2024-02-07FDA-DeviceClass IITerragene 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)
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
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