T2 Biosystems Recalls T2Candida Cartridges Due to Invalid Results
T2 Biosystems is recalling T2Candida Cartridges because they produced elevated levels of invalid results. The recall affects 6,864 units distributed to 17 states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves invalid diagnostic results, which poses a risk of harm to patients through potential misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
T2 Biosystems Inc is recalling T2Candida Cartridges, Part Numbers 90-01794 and 91-01534. These cartridges are used for a qualitative T2 Magnetic Resonance assay to detect Candida species in human whole blood specimens. The recall is being conducted because the product produced elevated levels of invalid results.
A total of 6,864 units are affected by this recall. The products were distributed to the states of Utah, Florida, New Hampshire, Pennsylvania, Georgia, Michigan, Alabama, Indiana, New Jersey, California, New York, Louisiana, Rhode Island, Tennessee, Texas, Wisconsin, and Connecticut. Specific lot numbers are listed in the official recall documentation.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected cartridges and contact T2 Biosystems Inc for further instructions or a refund.
The recalled product
- 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.
- Manufacturer
- T2 Biosystems Inc
- Hazard
- Affected units
- 6,864
Distribution
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