Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mi
Summary
The FDA issued a Class II for Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual ana by Siemens Healthcare Diagnostics, Inc.. Reason: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays.
Details
Source
Device Recall
External ID
Z-0330-2022
Action Date
2021-12-08
Status
Terminated
Category
device
Product Description
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 SMN: 10444801(US) and 10444802 (OUS)
Lot/Code Info: All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
Quantity Affected: 1407 units
Reason for Recall
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Distribution
Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-15
Company
Newark, DE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 131 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0330-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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