Dimension Vista¿ HbA1c — Class II medical device recall Z-0127-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-11-05, distributed nationwide. In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of
| Recall number | Z-0127-2015 |
|---|---|
| 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 | 2014-08-14 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 20,043 |
| Model numbers | K3105A |
Product
Dimension Vista¿ HbA1c
Reason for recall
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t
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-0127-2015. 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.