Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and…
Radiometer Medical ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI-DI05700693930923, 05700693930909 Software versions 3.6 and lower. ABL90 FLEX PLUS
- Instructions for Use versions prior to996-223
- Version202606O. ABL90 FLEX
- Instructions for Use versions prior to996-189
- Version202606L
- Amount recalled
- 5395
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Radiometer Medical ApS recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.