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.
Reported: December 25, 2013 Initiated: September 18, 2013 #Z-0541-2014
Product Description
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.
Reason for Recall
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 302
- Distribution
- 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.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 302.
Why was this product recalled? ▼
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0541-2014.
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