FDA Device recall Z-2795-2016
T2Candida¿Cartridges
- FDA Device
- Class II
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class II recall of T2Candida¿Cartridges by T2 Biosystems, citing elevated levels of invalid results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2795-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-07 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | T2 Biosystems |
| Distribution | AL, CA, CT, FL, GA, IN, LA, MI, NH, NJ, NY, PA, RI, TN, TX, UT, WI |
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.
Identifiers
| code_info | Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051…Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2795-2016%22
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