Class II recall Z-0190-2027: Radiometer Medical ApS
Class II recall Z-0190-2027: Radiometer Medical ApS: Radiometer Medical ApS. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 499 related FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Class II recall Z-0190-2027: Radiometer Medical ApS
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Class II recall Z-0190-2027: Radiometer Medical ApS + 500 peer records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records: SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · TECAR Therapy Device (TC2000, TC2001) (K252288) · Kentrospine Viktr-MIS® Pedicle screw system (K252139) · BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.
What is the FDAPulse record for Class II recall Z-0190-2027: Radiometer Medical ApS?
Class II device recall Z-0190-2027 by Radiometer Medical ApS: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and:
How does Class II recall Z-0190-2027: Radiometer Medical ApS compare to other FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class II recall Z-0190-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0190-2027 | 2026-10-21 | |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
Related records
- Class II recall Z-3155-2026: Philips North America Llc
- Class II recall Z-0232-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0243-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0258-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0211-2027: Life Technologies Holdings Pte Ltd
- Class II recall Z-0231-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0197-2027: Medtronic Navigation, Inc.
- Class II recall Z-0281-2027: Medline Industries, LP
- Class II recall Z-0229-2027: Boston Scientific Cork, Ltd.
- Class II recall Z-0196-2027: Medtronic Navigation, Inc.
- Class II recall Z-0275-2027: Medline Industries, LP
- Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.
Recent FDA Class II device recalls
How to monitor Class II recall Z-0190-2027: Radiometer Medical ApS and peer other records
Get new FDAPulse records like Class II recall Z-0190-2027: Radiometer Medical ApS by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.