Radiometer ABL90 FLEX Analyzer Recalled Due to Internal Clock Malfunction
Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.
What this means for you
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 medical device recall for a diagnostic analyzer with an internal clock malfunction. Although no illnesses or injuries have been reported, the clock issue represents a risk of harm to proper device operation and measurement accuracy, qualifying it as a risk-of-harm product under the rubric.
Plain-English summary
Radiometer Medical ApS is recalling the ABL90 FLEX Analyzer with E3800 PC units due to an issue with the internal clock. Approximately 3,346 analyzers are affected globally, with only 2 units reported in the United States. The E3800 CPU is also distributed as a spare part.
Affected analyzers have serial numbers R0996, R1000, and R1003 onwards. Units have been distributed to 43 U.S. states and to customers in 44 additional countries worldwide.
No illnesses or injuries have been reported in connection with this issue. Customers with affected devices should contact Radiometer Medical ApS for further information and replacement or repair options.
The recalled product
- Product
- Radiometer ABL90 FLEX 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 R1003 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.
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