Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2927-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 24, 2020

Date Posted: September 9, 2020

Recall Number: Z-2927-2020

Event ID: 86151

Reason for Recall:

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

Status: Terminated

Product Quantity: US: 1239 units OUS: 3387

Code Information:

Lot # 20008BB UDI: 0084276803771920135BB21031010471067840; Lot #20035BC UDI:0084276803771920035BC20113010471067840; Lot #20135BB UDI: 0084276803771920008BB20110310471067840

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated