FDA Device recall Z-0127-2015
Dimension Vista¿ HbA1c
- FDA Device
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Dimension Vista¿ HbA1c by Siemens Healthcare Diagnostics, citing in March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex®….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0127-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-14 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista¿ HbA1c
Reason
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
Identifiers
| code_info | catalog #K3105A, material #10470481, All in-date lots |
|---|
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-0127-2015%22
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