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

Recall Z-0675-2019 — ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or

U.S. FDA — Device Enforcement · United States · 2018-11-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0675-2019
Date of alert: 2018-11-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Tosoh Bioscience Inc
Product category: device
Product type: Devices

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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