FDA Medical Device Recalls (openFDA)
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 number
- Z-2927-2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2020-07-24
- Posted
- not on file
- Terminated
- 2023-06-07
- 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 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.
- Quantity
- US: 1239 units OUS: 3387
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840
- 510(k) numbers
- ["K182225"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28