Blood gases — Class II medical device recall Z-2494-2020
Terminated recall by Radiometer Medical ApS, reported 2020-07-15, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Potential risk of patient mix-up on analyzers due to software issues.
| Recall number | Z-2494-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, Denmark |
| Recall initiated | 2020-05-26 |
| Classified | 2020-07-04 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2023-02-08 |
| Distributed | 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 |
| Countries outside the US | AT, AU, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HR, HU, IN, IT, JP, KR, NL, NO, PL, RU, SE, SG, TR, ZA |
| Quantity | 3,899 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05700693938011 |
| Model numbers | 393-801 |
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 for recall
Potential risk of patient mix-up on analyzers due to software issues.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2494-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.