Terragene · Chrysalis Intelligence

Total clearances

2020-06-30 → 2025-08-04

Last 12 months

Product codes

Most recent

2025-08-04

Name variants in FDA filings: Terragene S.A. / Terragene

Trend

Clearance cadence by quarter

Portfolio

Code	Device name	Class	Specialty	Clearances	Most recent
FRC	Indicator, Biological Sterilization Process	Class II	General Hospital	4	2025-08-04
QVB	—	—	—	1	2024-07-12
QKM	A Chemical Vapor Sterilization Multivariable Chemical Indicator	Class II	General Hospital	1	2024-04-05
JOJ	—	—	—	1	2020-06-30

Safety

Class I (serious)

Risk of injury / death

Total recalls

Currently ongoing

Most recent

2025-01-15

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.

Filings

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	—	—
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	—	—