Z-2795-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- July 7, 2016
- Termination Date
- October 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,864
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.
Reason for Recall
Elevated levels of invalid results.
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.
Code Information
Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978