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

Recall Z-0541-2014 — Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and

U.S. FDA — Device Enforcement · United States · 2013-09-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0541-2014
Date of alert: 2013-09-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices

Reported risk: Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.

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.

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