The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and thera
Summary
The FDA issued a Class II for The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained tec by Radiometer Medical ApS. Reason: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including wh.
Details
Source
Device Recall
External ID
Z-0190-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
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/Code Info: UDI-DI: 05700693930923, 05700693930909 Software versions 3.6 and lower. ABL90 FLEX PLUS Instructions for Use versions prior to: 996-223, Version: 202606O. ABL90 FLEX Instructions for Use versions prior to: 996-189, Version: 202606L
Quantity Affected: 5395
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-18
Company
Bronshoj
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Radiometer Medical ApS has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Radiometer Medical ApS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Radiometer Medical ApS have FDA actions?
Radiometer Medical ApS has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0190-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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