FDA Device recall Z-0010-2019
ABL90 FLEX analyzers with software versions 3.3MR1 or below
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of ABL90 FLEX analyzers with software versions 3.3MR1 or below by Radiometer America, citing the ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0010-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-25 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Radiometer America |
| Distribution | n/a |
Product
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Reason
The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again
Identifiers
| code_info | ABL90 FLEX analyzers with software versions 3.3MR1 or below. |
|---|
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 - ABL800 analyzer, model numbers 393-800 and 393-801
FDA Device · Class II · 2019-01-02 · 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-0010-2019%22
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