FDA Enforcement
Class II
Terminated
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.
Recall: Z-2795-2016
·
Reported September 21, 2016
Enforcement
- Recall Number
- Z-2795-2016
- Event ID
- 74732
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- T2 Biosystems Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 21, 2016
- Initiation Date
- July 7, 2016
- Classification Date
- September 14, 2016
- Termination Date
- October 6, 2017
- Address
- 101 Hartwell Ave, N/A, Lexington, MA, 02421-3125, United States
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.
Reason
Elevated levels of invalid results.
Code Info
Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978
Distribution
Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.
Quantity
6,864