Device recall
Z-2795-2016: T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534…
FDA device recall · Class II · T2 Biosystems Inc
Key facts
| Recall number (Z-number) | Z-2795-2016 |
|---|---|
| Recall event | 74732 |
| Product | T2CandidaCartridges; 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. |
| Product code | PII |
| Recalling firm | T2 Biosystems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 6, 2017 |
| FEI number | 3010097867 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database