Radiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
Radiometer ABL90 FLEX and ABL90 FLEX PLUS analyzers running Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may freeze unexpectedly during sample measurement, causing test results to be lost and delayed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a software defect that causes operational freeze and sample loss. The source text does not report any illnesses, injuries, or hospitalizations. The hazard is delayed test results and lost samples, which is a functional impairment rather than direct patient harm, placing it in the Moderate category.
Plain-English summary
Radiometer Medical ApS is recalling Radiometer ABL90 FLEX (Model 393-090) and ABL90 FLEX PLUS (Model 393-092) blood analyzers running Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1.
These portable automated analyzers may unexpectedly freeze—ceasing to operate—during sample measurement. When a freeze occurs, the analyzer's watchdog software feature detects the freeze and automatically restarts the software to resume operation.
However, if a restart occurs while a sample is being processed, that sample will be lost. This can result in delayed test results. According to the source, approximately 6,275 analyzers have been distributed in the U.S. and internationally, including Canada and numerous other countries.
Facilities using affected analyzer models should identify which units are running Windows 10 versions RWIN10 1.0 or RWIN10 1.1. Contact Radiometer Medical ApS for guidance on software updates or device replacement options.
The recalled product
- Product
- 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
- Manufacturer
- Radiometer Medical ApS
- Hazard
- software-freeze
- sample-loss
- delayed-results
Distribution
Distributed in 48 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- PA
- RI
- SC
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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