Recall Z-2041-2016 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems Cat No. 02789602/SMN 1031 7708 (100 test) Cat No. 0279030
| Date | May 2, 2016 |
| Status | Terminated |
| Reason | Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin |
| Root cause | Component design/selection |
| Action | Siemens Healthcare sent an Urgent Medical Device Correction letter dated May 2, 2016, The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to continue use of the affected product, review the letter with their doctor, complete and return the Field Correction Effectiveness Check attached to the letter. If customers received any complaints of illness or adverse events associated wit the affected product they should immediately contact their local Siemens Customer Care Center or their local Siemens technical support representative. |
| Quantity | SMN 10317708 = 16434 kits and SMN 10317709 = 16033 kits |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary Iceland Italy Kazakhstan Latvia Lithuania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Healthcare, LLC, Dec 30, 2005 |