Z-2927-2020Class II

Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the...

Name: Z-2927-2020 Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-07-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-07-24 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in... on 2020-07-24. FDA classified it as Class II and gives the reason as "Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2927-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-24
Posted: 2020-09-02
Terminated: 2023-06-07
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
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
FDA 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 in commerce: US: 1239 units OUS: 3387
Distribution: Nationwide
Product codes and lots: Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2927-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2927-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-09	2020-09-02

Product code MMI

K182225Class IIDimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc. / cleared 2019-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)