FDA Device recall Z-2088-2013
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic…
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic… by Siemens Healthcare Diagnostics, citing siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which requi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2088-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-19 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. 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 fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use.
Reason
Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot
Identifiers
| code_info | Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 S…Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2088-2013%22
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