—#190257

Product

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)

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K051087, K143720
Affected lot / code info: All software versions prior to 3.10.2. GTIN: 00630414949581 and 00630414989556 (GTIN + Instrument Serial Number = Unique Device Identification (UDI)

Why it was recalled

Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

Root cause (FDA determination)

Software design

Action the firm took

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 feature is activated on your Dimension Vista System. If your laboratory is not using the HIL feature and it is not activated on your system no action is required: If the HIL indices for Dimension Vista FOL are activated, be sure to set the I index (icterus) to 6 which is aligned with the information in the Dimension Vista FOL IFU. If the HIL indices for Dimension Vista AMM are activated, be sure to set the L index (lipemia) to 2 which is aligned with the information in the Dimension Vista AMM IFU. Note: Instructions for setting HIL indices can be found in the Dimension System Operator s Guide, in Section Configuration, System Configuration. If the HIL indices for Dimension Vista CTNI are activated, be sure to set the I index (icterus) to 7 which is aligned with the information in the Dimension Vista CTNI IFU. If the HIL indices for Dimension Vista TPSA and/or FPSA are activated, be sure to set the H index (hemolysis) to 7 and the I index (icterus) to 6 which is aligned with the information in the Dimension Vista TPSA and FPSA IFUs. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your lo

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

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.

Timeline

Recall initiated: 2021-10-15
Terminated: 2024-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.