—#161506

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.

FDA product code: CDP — Radioimmunoassay, Total Triiodothyronine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K041133
Affected lot / code info: x

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: Worldwide Distribution - US Distribution.

Timeline

Recall initiated: 2017-07-28
Terminated: 2019-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161506. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.