Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Internal Clock Issue
Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 in the United States.
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 FDA Class II recall involves a medical device with an internal clock malfunction. Because medical devices directly impact patient safety, a device malfunction represents a risk-of-harm situation. Although no illnesses or injuries have been reported, the potential for patient harm from the device failure warrants a High severity rating per the rubric.
Plain-English summary
Radiometer Medical ApS is recalling the ABL90 FLEX PLUS Analyzer with E3800 PC units due to an issue with the internal clock. The E3800 CPU is also used as a spare part.
This recall affects approximately 4,135 analyzers worldwide, of which 1,277 units are in the United States. The affected model is ABL90 FLEX PLUS (393-092) with serial numbers R0214, R0218, or R0223 and onwards.
The recalled product
- Product
- Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
- Manufacturer
- Radiometer Medical ApS
- Hazard
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 (1)
- and R0223 onwards
Distribution
Part of a larger recall action
This product is one of 3 recalled by Radiometer Medical ApS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Radiometer Medical ApS
See all →- ModerateRadiometer ABL90 Series Blood Analyzers May Unexpectedly Freeze
FDA (Devices) · 2025-04-30
- HighABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
FDA (Devices) · 2024-07-31
- HighRadiometer AQURE Software Recall Due to Patient Mix-up Risk
FDA (Devices) · 2023-04-26
- HighABL800 Flex Analyzer Recalled for Potential Measurement Bias
FDA (Devices) · 2022-07-13
- HighRadiometer Arterial Blood Sampler recalled due to sterility guarantee loss
FDA (Devices) · 2022-05-25
Same hazard · clock malfunction
See all →- HighRadiometer ABL90 FLEX Analyzer Recalled Due to Internal Clock Malfunction
FDA (Devices) · 2021-06-23
Similar recalls
- SevereRadiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect
FDA (Devices) · 2020-05-06
- HighRadiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities
FDA (Devices) · 2019-08-28
- HighRadiometer ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation
FDA (Devices) · 2020-04-29
- HighRadiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch
FDA (Devices) · 2019-01-02
- HighRadiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
FDA (Devices) · 2020-06-03
- HighRadiometer ABL800 FLEX Blood Gas Analyzer Software Recall
FDA (Devices) · 2020-07-15