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Terminated

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.

FDA Recall Z-0720-2018 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeCDP
Date Initiated2017-07-28
Date Terminated2019-04-03
Product Quantity33,298

Reason for Recall

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.

Firm Action

Siemens sent an Urgent Medical Device Correction letter dated July 28, 2017, that was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States. On August 15, 2017 Follow-up communication was sent to all customers. For further questions, please call (508) 668-5000.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZERBayer Healthcare, LLC · 2004-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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