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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69739

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 10, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Tecan US, 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

2 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 2

Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.

Z-0991-2015
Recall number
Z-0991-2015
Initiated
November 10, 2014
Classification
Class III
Status
Terminated
Recalling firm
Tecan US, Inc.
Quantity
8 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Incorrect lumi firmware

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect lumi firmware version installed (E.027 instead of V2.00)

Code information

Material number: 30016056, Lot numbers: 708004532, 810007441, 906000758.

Distribution pattern

Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.

device · product 2 of 2

Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.

Z-0992-2015
Recall number
Z-0992-2015
Initiated
November 10, 2014
Classification
Class III
Status
Terminated
Recalling firm
Tecan US, Inc.
Quantity
Unavailable

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Incorrect lumi firmware

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect lumi firmware version installed (E.027 instead of V2.00)

Code information

Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591.

Distribution pattern

Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.

Field note

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