Recall Z-2135-2019 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
| Date | May 29, 2019 |
| Status | Terminated |
| Reason | Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. |
| Root cause | Under Investigation by firm |
| Action | On May 29, 2019, Siemens issued Urgent Medical Device Correction notices to U.S.A. customers via FedEx courier service and Urgent Field Safety Notices to international customers via email. Actions to be Taken by the Customer: 1. Do not use TestPaks within 2 mos of expiration. 2. Repeat samples with cTNL results above 0.07 ng/mL or your institution's established 99th percentile value. 3. Complete and return the Field Correction Effectiveness Check form 4. Retain a copy of the letter with your laboratory records and forward a copy of the notice to anyone to whom you may have distributed the p |
| Quantity | 2312 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. Dade Behring, Inc., Sep 8, 2005 |