ABL800 Flex Analyzer Recalled for Potential Measurement Bias
Radiometer Medical is recalling ABL800 Flex Analyzers that may produce biased measurements in sodium, calcium, and potassium levels. Approximately 1,489 analyzers are affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical analyzer with potential for measurement bias. It qualifies as a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Radiometer Medical is recalling the ABL800 Flex Analyzer models 393-800 and 393-801 due to a potential software issue affecting measurement accuracy.
The analyzers may produce sporadic positive or negative measurement biases in systems configured to measure sodium (cNa+), calcium (cCa+), and potassium (cK+) levels. This affects analyzer systems worldwide, with approximately 1,489 units distributed to healthcare facilities in the United States and numerous countries globally.
Customers using affected analyzers should contact Radiometer Medical for information about software updates and corrective actions. The recall involves all ABL800 Flex Analyzers running software versions below V6.19 MR2.
The recalled product
- Product
- ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
- Manufacturer
- Radiometer Medical ApS
- Hazard
- Affected units
- 1,489
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- All ABL800 Flex Analyzers containing software versions below V6.19 MR2
- UDI/DI ABL810
- 820
- and 830
- ABL805
- ABL815
- ABL825
- ABL835: 05700693938004
- UDI/DI ABL817
- ABL827
- ABL837: 05700693938011
Distribution
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