—#170408

Product

Dimension Vista 500, Analyzer, chemistry Model no. 10284473

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K051087
Affected lot / code info: Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374

Why it was recalled

When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On December 12, 2018, the firm issued Urgent Medical Device Correction letters to all Dimension Vista customers informing them of the issue. If customers have received a Progard Pretreatment Pack with a listed lot number, they are to follow the steps below upon Progard Pretreatment Pack installation and with use of the lots indicated. 1. Verify your water tank level is 85% or less on the WPM Maintenance screen (press Setup > Supplies > Maintain Water Supply > Maintenance). If your tank level exceeds 85%, use the Advanced->Diagnostics->Prime Pumps routine to lower the tank volume. 2. Replace the Progard filter and perform any other required maintenance as instructed in Section 7 of the Dimension Vista System Operators Guide. 3. After the Progard procedure completes, pause the instrument (Operation > Pause), and return to the WPM Maintenance screen (press Setup > Supplies > Maintain Water Supply > Maintenance) 4. Select the Refill Tank button. The process will take approximately 40 minutes to complete. An estimated time remaining is shown in the graphical user interface (GUI), and the white Status boxes in the top right indicate the steps of the process. 5. When complete, exit the WPM GUI by pressing Hide Window. An instrument reset is automatically performed as part of the process. 6. Process triglyceride QC and ensure all levels are in range. If QC is out of range, do not recalibrate triglyceride assay; contact your Siemens Technical Support Representative. If their instrument is currently using a Progard Pretreatment Pack from one of the affected lots listed, customers were instructed to process triglyceride QC to ensure that any contaminants have been purged from the system. If QC is out of range, they are not to recalibrate the triglyceride assay; contact their Siemens Technical Support Representative. If customers have received a Progard Pretreatment Pack with a lot number that is not listed, they are to continue to use the Progard Pretreatm

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide domestic distribution. Worldwide foreign distribution.

Timeline

Recall initiated: 2018-12-12
Terminated: 2020-04-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.