Recall Z-1991-2014 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
| Date | Jul 2, 2014 (initiated May 30, 2014) |
| Status | Terminated |
| Reason | The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent medical Device Correction (UMDC) was mailed, via FedEx, to all affected Siemens Healthcare Diagnostics customers in the United States on May 30, 2014 for customer receipt on June 2, 2014. All international customers were provided with a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer is asked to complete a fax-back form. This notice informed the customers of the potential for incorrect control and patient results due to solid phase which is darker in appearance. The notice inst |
| Quantity | 34,283 kits |
| Distribution | Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentin |
| 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 |