Dimension Vista 500- In-vitro diagnostic device recall
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring…
Why was Dimension Vista 500- In-vitro diagnostic device recalled?
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)
- Product
- Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1326 units
- 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.
- Recall date
- December 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)