Reported Apr 30, 2025 · Ongoing
Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX…
Radiometer Medical ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
- Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.
- Lot codes and dates
- Model Number393-090
- UDI-DI05700693930909
- Model Number393-092
- UDI-DI05700693930923
- Serial Numbers
1,778 of 1,778 codes
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
- Amount recalled
- 6275 analyzers
Where it was sold
Why it was recalled
ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
This product could cause temporary or reversible health problems — stop using it.
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