Reported Mar 17, 2021 · Ongoing
Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 · Newark, DE · 19702-2466
Is this the product you have?
- Dimension Vista HDLC - colorimetric method
- lipoproteins - Product Usageused as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease
- Lot codes and dates
- ProductDV HDLC; Lot #: 20062BA
- UDI Number0084276802043820062BA21030210464340840
- Amount recalled
- 4174 devices (Domestic: 2836 devices, Foreign: 1338 devices)
Where it was sold
Why it was recalled
Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
This product could cause temporary or reversible health problems — stop using it.
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