Recall Z-0720-2018 ยท CDP Radioimmunoassay, Total Triiodothyronine
Siemens Healthcare Diagnostics, Inc
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.
| Date | Jul 28, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by 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. |
| Quantity | 33,298 |
| Distribution | Worldwide Distribution - US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER Bayer Healthcare, LLC, Jul 2, 2004 |