Reported Apr 6, 2022 · Ongoing
Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the…
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?
- Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma, and urine on the Dimension Vista System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypomagnesemia (abnormally high plasma levels of magnesium).
- Lot codes and dates
- [lot 21253BB
- UDI
0084276801569421253BB22091010445158840][lot 21263BA
- UDI
0084276801569421263BA22092010445158840][lot 21335AA
- UDI0084276801569421335AA22120110445158840]
- Amount recalled
- 14220 (US 13305, OUS 915)
Where it was sold
Why it was recalled
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.
This product could cause temporary or reversible health problems — stop using it.
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