Reported Sep 21, 2016 · Terminated

T2Candida¿Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A…

T2 Biosystems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: T2 Biosystems Inc · 101 Hartwell Ave · Lexington, MA · 02421-3125

Is this the product you have?

  • T2Candida¿Cartridges
  • Part Number90-01794 (box
  • of 12) and Part Number91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR¿) assay for the direct detection of Candida species in EDTA human whole blood specimens
Lot codes and dates
  • Lot Numbers
    • 000048532541
    • 000048730657
    • 000049837721
    • 000050205643
    • 000050205642
    • 000050205641
    • 000050205644
    • 000051259462
    • 000051269868
    • 000051807669
    • 000051989614
    • 000052596978
Amount recalled
6,864

Where it was sold

Why it was recalled

Elevated levels of invalid results.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new T2 Biosystems Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 6, 2017 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.