FDA Device recall Z-0330-2022
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and…
- FDA Device
- Class II
- terminated
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and… by Siemens Healthcare Diagnostics, citing incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0330-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-15 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista 1500 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 fluid SMN: 10444801(US) and 10444802 (OUS)
Reason
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
Identifiers
| code_info | All software versions prior to 3.10.2. GTIN: 00630414949741 and 00630414945460 (GTIN + Instrument Serial Number = Unique Device Identification (UDI) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0330-2022%22
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