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

Recall date

July 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2795-2016

FDA classification

Class II

Brand / firm

T2 Biosystems Inc

Sold / distributed

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

Why it was recalled

Elevated levels of invalid results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.