FDA Device recall Z-1858-2021
E3800 PC Units (spare parts)
- FDA Device
- Class II
- ongoing
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of E3800 PC Units (spare parts) by Radiometer Medical Aps, citing due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1858-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-14 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Radiometer Medical Aps |
| Distribution | US |
Product
E3800 PC Units (spare parts)
Reason
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Identifiers
| code_info | Part number: 910-414 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1858-2021%22
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