Alvear, AR · 7 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | Class II | General Hospital | 4 | 2025-08-04 |
| QVB | Biological Sterilization Indicator With Indirect Growth Detection | Class II | General Hospital | 1 | 2024-07-12 |
| QKM | A Chemical Vapor Sterilization Multivariable Chemical Indicator | Class II | General Hospital | 1 | 2024-04-05 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | Class II | General Hospital | 1 | 2020-06-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-01-15 | Class II | Ongoing | Z-1248-2025 | ASP 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. |
| 2023-12-07 | Class II | Ongoing | Z-0837-2024 | 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. |
| 2023-12-07 | Class II | Ongoing | Z-0836-2024 | Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] T… | — | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-04 | K251122 | Terragene® Bionova® BT20 Biological Indicator | FRC | Class II | General Hospital |
| 2024-12-12 | K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | FRC | Class II | General Hospital |
| 2024-09-18 | K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | FRC | Class II | General Hospital |
| 2024-07-12 | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) | QVB | Class II | General Hospital |
| 2024-04-05 | K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | QKM | Class II | General Hospital |
| 2023-02-28 | K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | FRC | Class II | General Hospital |
| 2020-06-30 | K200272 | Terragene Chemdye | JOJ | Class II | General Hospital |