Recall Z-1654-2014 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
| Date | May 23, 2014 (initiated Apr 10, 2014) |
| Status | Terminated |
| Reason | Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays. |
| Root cause | Device Design |
| Action | Siemens Healthcare Urgent Medical Device Correction (UMDC) was mailed to all affected Siemens Healthcare Diagnostics customers in the United States on April 11, 2014 for customer receipt on April 14, 2014. This notice informed the customers of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra and Vitamin D Total assays. This notice instructs customers that the TSH3-Ultra and Vitamin D assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. |
| Quantity | 155,345 kits |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazak |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083844 | ADVIA CENTAUR TSH3-ULTRA METHOD Siemens Healthcare Diagnostics, May 8, 2009 |