International Medical Devices Database

Manufacturer Address
T2 Biosystems Inc, 101 Hartwell Ave, Lexington MA 02421-3125
Manufacturer Parent Company (2017)
T2 Biosystems, Inc.
Source
USFDA
1 Event
- Recall of Device Recall T2CandidaCartridges

One device in the database

Device Recall T2CandidaCartridges

Model / Serial
Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.
Product Description
T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). || A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens.

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)

T2 Biosystems Inc

One device in the database

Device Recall T2CandidaCartridges