T2 Biosystems Inc: Medical Device Recall in 2016 - (Recall #: Z-2795-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 7, 2016

Date Posted: September 21, 2016

Recall Number: Z-2795-2016

Event ID: 74732

Reason for Recall:

Elevated levels of invalid results.

Status: Terminated

Product Quantity: 6,864

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.

Voluntary or Mandated:

Voluntary: Firm initiated