Recall Z-2795-2016— T2 Biosystems Inc
Class II · Terminated
Class II FDA medical device recall by T2 Biosystems Inc, initiated 2016-07-07, terminated 2017-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- T2 Biosystems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-07
- Terminated
- 2017-10-06
- Firm location
- Lexington, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.