Devices

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.
Manufacturer
T2 Biosystems Inc
1 Event
- Recall of Device Recall T2CandidaCartridges

Manufacturer

T2 Biosystems Inc

Manufacturer Address
T2 Biosystems Inc, 101 Hartwell Ave, Lexington MA 02421-3125
Manufacturer Parent Company (2017)
T2 Biosystems, Inc.
Source
USFDA

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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.

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