Z-1015-2019Class II

Dimension Vista 1500, Analyzer, chemistry Model no. 10444801

Name: Z-1015-2019 Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2018-12-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-12-12 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 on 2018-12-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1015-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-12
Posted: 2019-03-15
Terminated: 2020-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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 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 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.
Product codes and lots: Millipore lot number: F7MA50339 F7MA56608 F7NA62488 F8AA13966 F8AA93567 F8BA20457 F8BA35774 F8DA59251 F8HA64477 F8HA79819 F8HA91305 F8JA97876 F8MA06374

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1015-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1014-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-15
Z-1015-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-27	2019-03-15

Product code JJE

K143720Class IIDimension Vista MMB AssaySiemens Healthcare Diagnostics / cleared 2015-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)