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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74837

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

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Event summary

Timeline bucket
July 19, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Thermo Finnigan LLC

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

Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.

Z-2775-2016
Recall number
Z-2775-2016
Initiated
July 19, 2016
Classification
Class II
Status
Terminated
Recalling firm
Thermo Finnigan LLC
Quantity
6 (5 in Us distribuion and 1 in Japan)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software versions 1.0 and 1.0 SP! have a software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.

Code information

TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.

Distribution pattern

Worldwide distribution - US including FL, NY and Internationally to Japan.