Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well… — Class II medical device recall Z-2088-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-09-04, distributed nationwide. Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using softwa
| Recall number | Z-2088-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-06-19 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, KR, MY, NL, NO, NZ, PT, SI, SK, ZA |
| Quantity | 1,937 |
| Reason classes | software |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2088-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.