Recall Z-2494-2020— Radiometer Medical ApS
Class II · Terminated
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2020-05-26, terminated 2023-02-08. It names one FDA 510(k) clearance: K041874. Product: Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.. Reason: Potential risk of patient mix-up on analyzers due to software issues..
- Recalling firm
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-26
- Terminated
- 2023-02-08
- Firm location
- Bronshoj, Denmark
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
Reason for recall
Potential risk of patient mix-up on analyzers due to software issues.
Data sourced from openFDA. This site is unofficial and independent of the FDA.