Recall Z-2927-2020 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
| Date | Jul 24, 2020 |
| Status | Terminated |
| Reason | Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthcare issued Urgent Medical Device Correction (UMDC # VC-20-03.A.US) and Urgent Field Safety Notice (UFSN # VC-20-03.A.OUS) on July 24, 2020 to Dimension Vista customers who received the Dimension Vista TNIH reagent to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: "Review the letter with their Medical Director Use lot specific correlation factors with lots 20008BB, 20035BC, and 20135BB. Siemens is working to restore assay performance, until such time, subsequent lots may contain an alert card in th |
| Quantity | US: 1239 units OUS: 3387 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc., Mar 4, 2019 |