Recall Z-2207-2015 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: 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. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infa
| Date | Jul 23, 2015 (initiated May 19, 2015) |
| Status | Terminated |
| Reason | System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent an Urgent Medical Device Correction letter dated via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Field Correction Effectiveness Check attached to the letter. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative. |
| Quantity | SMN10317708 = 20544 kits & SMN 10317709 = 21159 kits |
| Distribution | Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, and Puerto Rico; and the countries of Algeria, Austria, Bahrain, Belgium |
| 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 |