Z-0331-2022 Class II Terminated
FDA device recall Z-0331-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on October 15, 2021 and is designated Class II. Reason for recall: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays The recall status is terminated (terminated May 13, 2024). Affected quantity: 1326 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- October 15, 2021
- Termination Date
- May 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1326 units
Product Description
Dimension Vista 500- 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: 10284473 (US) and 10488224 (OUS)
Reason for Recall
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Distribution Pattern
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.
Code Information
All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)