—#182848

Product

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

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K182225
Affected lot / code info: Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2020-07-24
Terminated: 2023-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.