TERRAGENE S.A.
FDA Regulatory Profile
TERRAGENE S.A. appears in FDA public data with 3 recalls, 9 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-1248-2025, Class II) was initiated on January 15, 2025. Its most recent 510(k) clearance was granted on August 4, 2025.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 9
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1248-2025 | Class II | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. | January 15, 2025 |
| Z-0837-2024 | Class II | Terragene Bionova PCD (PCD222-C) | December 7, 2023 |
| Z-0836-2024 | Class II | Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integr | December 7, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251122 | Terragene® Bionova® BT20 Biological Indicator | August 4, 2025 |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragen | December 12, 2024 |
| K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained B | September 18, 2024 |
| DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubato | July 12, 2024 |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process In | April 5, 2024 |
| K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubat | February 28, 2023 |
| K200272 | Terragene Chemdye | June 30, 2020 |
| K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | September 13, 2019 |
| K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220- | November 2, 2017 |