Reported Dec 8, 2021 · Terminated
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting,…
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 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety
- of analytes in human body fluid SMN10444801(US) and 10444802 (OUS)
- Lot codes and dates
- All software versions prior to 3.10.2
- GTIN00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
- Amount recalled
- 1407 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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