| Date Initiated by Firm |
December 12, 2018 |
| Create Date |
March 15, 2019 |
| Recall Status1 |
Terminated 3 on April 27, 2020 |
| Recall Number |
Z-1014-2019 |
| Recall Event ID |
81955 |
| 510(K)Number |
K051087
|
| Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
| Product |
Dimension Vista 500, Analyzer, chemistry Model no. 10284473 |
| Code Information |
Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374 |
Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Newark DE 19702-2466
|
| For Additional Information Contact |
Siemens Customer Care Center
800-743-6367
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
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 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 |
| Quantity in Commerce |
5373 |
| Distribution |
Nationwide domestic distribution. Worldwide foreign distribution. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
|
