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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples

Recommended Action

Per FDA guidance

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 the carton containing lot specific correlation factors ."Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. "If they have received any complaints of illness or adverse events associated with the product listed in Table 1 of the letter, immediately contact their local Siemens Remote Services Center or their local Siemens Technical Support Representative. Questions, please contact your Siemens Remote Services Center or your local Siemens Technical Support.