T2 Biosystems Inc recalls T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qual

Recalled September 21, 2016 · FDA recall Z-2795-2016 · T2 Biosystems

Hazard

Elevated levels of invalid results. · FDA Class II

Units

6,864

Sold at

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

Description

Elevated levels of invalid results.

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.

Manufacturer(s)

T2 Biosystems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →