Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

T2Candida¿Cartridges Recalled by T2 Biosystems Inc Due to Elevated levels of invalid results.

Date: July 7, 2016
Company: T2 Biosystems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact T2 Biosystems Inc directly.

Affected Products

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.

Quantity: 6,864

Why Was This Recalled?

Elevated levels of invalid results.

Where Was This Sold?

This product was distributed to 17 states: AL, CA, CT, FL, GA, IN, LA, MI, NH, NJ, NY, PA, RI, TN, TX, UT, WI

Affected (17 states)Not affected

About T2 Biosystems Inc

T2 Biosystems Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report