Z-2795-2016Class II

T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base)...

Name: Z-2795-2016 T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base)...
Creator: T2 Biosystems Inc
Published: 2016-07-07
License: https://open.fda.gov/license/

T2 Biosystems Inc / initiated 2016-07-07 / Terminated

FDA source

T2 Biosystems Inc began a recall of T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR) assay... on 2016-07-07. FDA classified it as Class II and gives the reason as "Elevated levels of invalid results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2795-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Posted: 2016-09-14
Terminated: 2017-10-06
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.
Product code: PII Candida Species Nucleic Acid Detection System
Reason for recall: Elevated levels of invalid results.
FDA 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 [email protected] or via fax to 781-240-0541. Your primary contact at T2 for all recall-related correspondence or questions is Georgette Yannios ([email protected] 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 in commerce: 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.
Product codes and lots: Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2795-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2795-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14

Product code PII

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)