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.
FDA Recall Z-0541-2014 · Posted 2013-12-19
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeLPS
Date Initiated2013-09-18
Date Terminated2014-10-01
Product Quantity302
Reason for Recall
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
Firm Action
Siemens sent a Urgent Medical Device Recall letter dated September 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
Actions to be taken by Customer:
Please discontinue use and discard any remaining inventory of Dimension Vista HCYS Flex reagent cartridge (Catalog# K7044) lot 13064MA.
Please complete the attached form and fax it to (302) 631-8467 to facilitate your no charge replacement needs.
Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center- Technical Solutions or your local Siemens technical support representative.
For further questions please call (800) 441-9250.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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