Dimension Vista — Class II medical device recall Z-0017-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-10-23, distributed nationwide. Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal
| Recall number | Z-0017-2014 |
|---|---|
| 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 | 2012-12-19 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Quantity | 3,395 |
| Lot numbers | 11349BB |
Product
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System.
Reason for recall
Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.
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-0017-2014. 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.