Recall Z-2795-2016 ยท PII Candida Species Nucleic Acid Detection System
T2 Biosystems Inc
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.
| Date | Jul 7, 2016 |
| Status | Terminated |
| Reason | Elevated levels of invalid results. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified of the recall vie e-mail and certified mail on July 7, 2016, with an Urgent Medical Device Recall letter. Customers were asked to take the following actions: 1. Please examine your current inventory and determine whether you have any of the recalled lots listed. (a.) If you DO have cartridges from the recalled lots, please note the quantity of cartridges you have of each lot number on the attached form entitled T2Candida Cartridge Recall Customer Response Form (CRF). Please also immediately quarantine any cartridges from the indicated lots and do not use them. (b.) |
| Quantity | 6,864 |
| Distribution | Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.