Recall Z-0331-2022 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
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)
| Date | Oct 15, 2021 |
| Status | Terminated |
| Reason | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| Root cause | Software design |
| Action | Siemens issued Urgent Medical Device Correction letter dated 10/27/21 to US Customers (VSW-22-01.A.US) and OUS Customers will be sent Urgent Field Safety Notice (VSW-22-01.A.OUS) to inform them of the issue and instruct them on setting the HIL index for the affected assays if applicable. The Dimension Vista software has been updated with the correct HIL index default settings recommended in this letter and included in software version 3.10.2. Letter states reason for recall, health risk and action to take: For the products listed in Table 1, please perform the following steps if the HIL feat |
| 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. |
| FDA record | Open on fda.gov |