T2Candida¿Cartridges — Class II medical device recall Z-2795-2016
Terminated recall by T2 Biosystems Inc, reported 2016-09-21, distributed in AL, CA, CT, FL, GA, IN, LA, MI…. Elevated levels of invalid results.
| Recall number | Z-2795-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | T2 Biosystems Inc, Lexington, MA, United States |
| Recall initiated | 2016-07-07 |
| Classified | 2016-09-14 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-10-06 |
| Distributed | AL, CA, CT, FL, GA, IN, LA, MI, NH, NJ, NY, PA, RI, TN, TX, UT, WI |
| Quantity | 6,864 |
| Lot numbers | 000048532541, 000048730657, 000049837721, 000050205641, 000050205642, 000050205643, 000050205644, 000051259462, 000051269868, 000051807669, 000051989614, 000052596978 |
| Model numbers | 90-01794, 91-01534 |
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 for recall
Elevated levels of invalid results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2795-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.