FDA recall Z-0331-2022

Siemens Healthcare Diagnostics, Inc. · Class II · device

Product

Dimension Vista 500- 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: 10284473 (US) and 10488224 (OUS)

Reason for recall

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

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2021-10-15
Report date: 2021-12-08
Termination date: 2024-05-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Newark, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0331-2022