Drug recall
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004…
FDA recall event 85700 · Class II · Radiometer Medical ApS
Key facts
| Event ID | 85700 |
|---|---|
| Recall numbers | Z-2493-2020, Z-2494-2020 |
| Recalling firm | Radiometer Medical ApS |
| Product type | Devices |
| 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential risk of patient mix-up on analyzers due to software issues. |
| Initiation date | May 26, 2020 |
| Report date | Jul 15, 2020 |
| Termination date | Feb 8, 2023 |
| City | Bronshoj |
| Country | Denmark |
| FEI number | 3002807968 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: