Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0331-2022 — 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)

U.S. FDA — Device Enforcement · United States · 2021-10-15 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0331-2022
Date of alert: 2021-10-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00630414949581

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0331-2022 — 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)

Related