FDA Device recall Z-2494-2020
Blood gases (PCO2, PO2) and blood pH test system
- FDA Device
- Class II
- terminated
- Published 2020-07-15
On 2020-07-15 the FDA classified a Class II recall of Blood gases (PCO2, PO2) and blood pH test system by Radiometer Medical Aps, citing potential risk of patient mix-up on analyzers due to software issues.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2494-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-26 |
| Published | 2020-07-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Radiometer Medical Aps |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
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.
Identifiers
| code_info | Software versions 6.19 and below. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2494-2020%22
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