Recall Z-1014-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
| Date | Dec 12, 2018 |
| Status | Terminated |
| Reason | 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 | Under Investigation by firm |
| Action | 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 |
| Quantity | 5373 |
| Distribution | Nationwide domestic distribution. Worldwide foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |