FDA Device recall Z-1856-2021
Radiometer ABL90 FLEX Analyzer with E3800 PC units
- FDA Device
- Class II
- ongoing
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of Radiometer ABL90 FLEX Analyzer with E3800 PC units 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-1856-2021 |
| 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
Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Reason
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Identifiers
| code_info | Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards |
|---|
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-1856-2021%22
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