Events

Recall of Device Recall T2CandidaCartridges

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by T2 Biosystems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74732
  • Event Risk Class
    Class 2
  • Event Number
    Z-2795-2016
  • Event Initiated Date
    2016-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148334
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Candida species nucleic acid detection system - Product Code PII
  • Reason
    Elevated levels of invalid results.
  • 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.) If you DO NOT have any cartridges from the recalled lots, please also note this in the space provided on the form 2. Send the completed CRF to T2Biosystems via e-mail to orders@t2biosystems.com or via fax to 781-240-0541. Your primary contact at T2 for all recall-related correspondence or questions is Georgette Yannios (gyannios@t2biosystems.com or 877-504-8282 Option 3). All product will be replaced at no charge to you as soon as possible. 3. Once T2 receives the CRF, we will issue a Return Material Authorization (RMA) number to you along with a FedEx shipping label. After you receive this RMA number and label, please follow the instructions provided with the RMA for shipment of cartridges back to T2 (please do not ship reagent trays as they are not subject to this action).

Device

Device Recall T2CandidaCartridges
  • Model / Serial
    Lot Numbers:  000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.
  • Product Description
    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

Manufacturer

T2 Biosystems Inc
  • Manufacturer Address
    T2 Biosystems Inc, 101 Hartwell Ave, Lexington MA 02421-3125
  • Manufacturer Parent Company (2017)
    T2 Biosystems, Inc.
  • Source
    USFDA