FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2795-2016
- Recalling firm
- T2 Biosystems Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-07-07
- Posted
- not on file
- Terminated
- 2017-10-06
- 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.) 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).
- 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.
- Lot, serial or model codes
- Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PII
- Firm FEI
- 3010097867
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28