# Class II recall Z-0190-2027: Radiometer Medical ApS

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0190-2027 |
| Recalling firm | Radiometer Medical ApS |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order. |
| Reason | In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings. |
| Quantity | 5395 |
| Distribution | US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI. |
| Recall initiated | 2026-08-18 |
| Reported | 2026-10-21 |
| Firm location | Bronshoj, Denmark |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 15 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0190-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.