Dimension Vista Blood Urea Nitrogen — Class II medical device recall Z-1622-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-05-18, distributed nationwide. Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 152
| Recall number | Z-1622-2016 |
|---|---|
| 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 | 2016-02-16 |
| Classified | 2016-05-06 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-12-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BS, CA, CH, CZ, DE, DK, ES, FI, FR, IT, JP, KR, NO, NZ, PT, SI, SK |
| Quantity | 18,668 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | 15215AE, 15243BB, 15264BA, 15299BB, 15300BA, 15320BB, 15341AC |
Product
Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
Reason for recall
Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities.
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-1622-2016. 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.