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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74732

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 07, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
T2 Biosystems Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2795-2016
Recall number
Z-2795-2016
Initiated
July 07, 2016
Classification
Class II
Status
Terminated
Recalling firm
T2 Biosystems Inc
Quantity
6,864

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Elevated levels of invalid results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Elevated levels of invalid results.

Code information

Lot Numbers: 000048532541 000048730657 000049837721 000050205643 000050205642 000050205641 000050205644 000051259462 000051269868 000051807669 000051989614 000052596978

Distribution pattern

Distributed to the states of UT, FL, NH, PA, GA, MI, AL, IN, NJ, CA, NY, LA, RI, TN, TX, WI, and CT.

Field note

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