Reported Nov 14, 2012 · Terminated
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the…
Siemens Healthcare Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr Ms 514 · Newark, DE · 19702-2466
Is this the product you have?
- Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
- Lot codes and dates
Lot numbers 12062MAexp 12/01/2012and 12066MAexp 12/05/2012
- Amount recalled
- 583 cartons
Where it was sold
Why it was recalled
Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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