Device product

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.

Z-2795-2016

July 07, 2016

Class II

Product summary

Firm: T2 Biosystems Inc
Event: Event 74732
Status: Terminated
Classification: Class II
Quantity: 6,864
Official record key: device-enforcement:Z-2795-2016

Official wording

Reason: Elevated levels of invalid results.

Code information: Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978

Distribution pattern: Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Elevated levels of invalid results.