FDA Device recall Z-0682-2019
ABL800 analyzer, model numbers 393-800 and 393-801
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of ABL800 analyzer, model numbers 393-800 and 393-801 by Radiometer America, citing the analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0682-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-03 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Radiometer America |
| Distribution | US |
Product
ABL800 analyzer, model numbers 393-800 and 393-801.
Reason
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
Identifiers
| code_info | Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL…Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Radiometer America
- ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
FDA Device · Class II · 2019-08-28 · Radiometer America - Product: ABL800 FLEX with Crea
FDA Device · Class II · 2019-02-13 · Radiometer America - ABL90 FLEX analyzers with software versions 3.3MR1 or below
FDA Device · Class II · 2018-10-10 · Radiometer America - ABL800 analyzer with FLEXQ module
FDA Device · Class II · 2017-12-20 · Radiometer America - AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are…
FDA Device · Class II · 2017-10-11 · Radiometer America
All Radiometer America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0682-2019%22
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