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U.S. Department of Health and Human Services

Class 2 Device Recall ABL90 FLEX and ABL90 FLEX PLUS

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 Class 2 Device Recall ABL90 FLEX and ABL90 FLEX PLUSsee related information
Date Initiated by FirmMarch 21, 2025
Date PostedApril 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1659-2025
Recall Event ID 96515
510(K)NumberK092686 K160153 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductRadiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.
Code Information Model Number: 393-090 UDI-DI: 05700693930909 Model Number: 393-092 UDI-DI: 05700693930923 Serial Numbers: 090R0643N002 090R0749N001 090R0757N002 090R0757N004 090R0861N018 090R0874N009 090R0874N011 090R0874N012 090R0892N012 090R0897N023 090R0902N025 090R0943N010 090R0965N003 090R0965N007 090R0965N009 092R0150N001 092R0173N047 092R0173N049 092R0177N055 092R0180N011 092R0180N014 092R0180N025 092R0180N027 092R0185N022 092R0185N024 092R0185N025 092R0185N026 092R0187N016 092R0187N019 092R0187N021 092R0187N026 092R0187N027 092R0188N022 092R0188N024 092R0188N025 092R0188N026 092R0188N027 092R0188N028 092R0188N029 092R0188N033 092R0191N002 092R0195N034 092R0197N026 092R0197N028 092R0197N031 092R0198N005 092R0198N006 092R0198N008 092R0198N009 092R0198N014 092R0198N019 092R0198N027 092R0198N031 092R0200N041 092R0201N001 092R0201N003 092R0201N004 092R0201N006 092R0201N008 092R0204N035 092R0204N036 092R0214N011 092R0214N012 092R0214N013 092R0216N003 092R0216N004 092R0216N005 092R0216N006 092R0216N007 092R0216N016 092R0216N017 092R0216N020 092R0216N021 092R0218N014 092R0218N047 092R0218N048 092R0218N050 092R0221N011 092R0223N008 092R0223N011 092R0223N024 092R0223N026 092R0223N048 092R0223N050 092R0225N032 092R0225N039 092R0225N049 092R0225N050 092R0225N051 092R0225N052 092R0225N053 092R0225N054 092R0226N001 092R0226N002 092R0226N003 092R0226N015 092R0226N016 092R0226N018 092R0226N019 092R0227N047 092R0227N050 092R0227N051 092R0227N053 092R0227N054 092R0227N055 092R0227N056 092R0227N062 092R0227N077 092R0227N078 092R0228N007 092R0228N008 092R0228N030 092R0229N040 092R0229N052 092R0230N029 092R0230N030 092R0230N033 092R0230N037 092R0230N059 092R0230N068 092R0230N069 092R0230N070 092R0231N004 092R0231N007 092R0231N012 092R0231N013 092R0231N015 092R0231N016 092R0231N024 092R0231N029 092R0231N030 092R0231N031 092R0231N032 092R0231N033 092R0231N034 092R0231N035 092R0231N037 092R0231N040 092R0232N054 092R0233N024 092R0233N026 092R0234N006 092R0234N008 092R0234N009 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Recalling Firm/
Manufacturer		 Radiometer Medical ApS
Akandevej 21
Bronshoj Denmark
For Additional Information ContactTechnical Support, Radiometer America Inc.
800-736-0600 Ext. 1
Manufacturer Reason
for Recall		ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.
FDA Determined
Cause 2		Component design/selection
ActionOn 03/21/2025, the firm sent via email and FedEx an "Urgent: Medical Device Recall" Letter informing customers that, Radiometer has become aware of a potential risk with ABL90 FLEX and ABL90 FLEX PLUS analyzers when operating with Radiometer Windows 10 versions (RWIN10 1.0 and 1.1). Specifically, the analyzer software may unexpectedly "freeze" and restart during a sample measurement, causing the analyzer to cease operation during the startup period. Customers are instructed to: 1. Do not use the affected systems without having an alternative solution readily available. Alternative solutions could include using an additional analyzer or sending the sample to a central laboratory. This also involves ensuring that there is enough patient sample for a second measurement, in case the sample is lost due to the analyzer restarting. Additionally, we ask that you please post a copy of this letter on or near the device(s) until such time that the software has been upgraded. Radiometer will contact customers to schedule the upgrade to analyzers to the available software RWIN10 1.2 or greater. For questions, contact Radiometer at 1-800-736-0600 option 1, Monday - Friday 9 AM to 7 PM (EST).
Quantity in Commerce6275 analyzers
DistributionU.S.: AL, AR, AZ, BM CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, Ireland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CHL
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