FDA recall, , Moderate risk
Radiometer Medical ABL90 FLEX and ABL90 FLEX PLUS Analyzers
The ABL90 Flex and ABL90 Flex Plus analyzers have a risk of potentially inaccurate results.
Summary by Recall Canary from the FDA notice
What happened
Radiometer Medical ApS began a recall of the ABL90 FLEX and ABL90 FLEX PLUS analyzers on August 18, 2026, because the in vitro diagnostic analyzer had a risk of potentially inaccurate results.
The agency described changes to instructions for use, including sample types no longer suitable for testing FHbF and ctBil, reportable ranges for some parameters, analyzer configuration, and limitations and warnings. The recall was added to the FDA's Enforcement Report and classified on October 15, 2026, with US Nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
The ABL90 Flex and ABL90 Flex Plus analyzers
- UDI-DI
- 05700693930923
- 05700693930909
- 3.6
- 996-223
- 202606O
- 996-189
- 202606L
Recall details
- Company began the recall
- Sold in
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.
- Company
- Radiometer Medical ApS
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99772
- Recall number
- Z-0190-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
