FDAFDA · Food and drugs·Recall number 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 treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Published December 25, 2013 · Recall initiated: September 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution - US Distribution including the states of OH, MD, CO, NJ, IA, NC, VA, WI and DC., and the countries of Austria, Denmark, France, Italy, Netherlands and Norway.
- Lot
- lot 13064MA, expiration 2014-03-05
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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