Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.
Hazard
Potential risk of patient mix-up on analyzers due to software issues.
What You Should Do
Remedy
On 05/26/2020, the firm sent an Urgent: Medical Device Recall letter via email to all consignees; additionally the firm will send a hard copy letter FedEx 2nd day with tracking and proof of delivery.
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Products
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825,
- Brand
- Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
- UPC
- Software versions 6.19 and below.
Units Affected
4,615 units