FDAFDA · Food and drugs·Recall number 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 homocysteinuria.
Published January 2, 2019 · Recall initiated: November 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tosoh Bioscience Inc
- Distributor
- US Nationwide
- Lot
- all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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