Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0330-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)

Product Classification:

Class II

Date Initiated: October 15, 2021

Date Posted: December 8, 2021

Recall Number: Z-0330-2022

Event ID: 89008

Reason for Recall:

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

Status: Terminated

Product Quantity: 1407 units

Code Information:

All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.

Voluntary or Mandated:

Voluntary: Firm initiated