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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease.

Z-0720-2018

July 28, 2017

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 79170
Status
Terminated
Classification
Class II
Quantity
33,298
Official record key
device-enforcement:Z-0720-2018

Official wording

Reason: Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.

Code information: x

Distribution pattern: Worldwide Distribution - US Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.