Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (…

Recall date
July 28, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0720-2018
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc
Sold / distributed
Worldwide Distribution - US Distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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