Home / Recalls / Radiometer Medical ApS / Z-1659-2025

Z-1659-2025 Class II Ongoing

Recalled by Radiometer Medical ApS — Bronshoj, N/A

FDA device recall Z-1659-2025 was initiated by Radiometer Medical ApS on March 21, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 6275 analyzers.

Recall Details

Product Type
Devices
Report Date
April 30, 2025
Initiation Date
March 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6275 analyzers

Product Description

Radiometer 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.

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.

Distribution Pattern

U.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

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 092R0234N010 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Other recalls by Radiometer Medical ApS

  • Z-2426-2024 Class II — ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are (May 31, 2024)
  • Z-1394-2023 Class II — AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQ (March 8, 2023)
  • Z-1321-2022 Class II — ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 (May 18, 2022)
  • Z-1115-2022 Class II — Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrol (April 8, 2022)
  • Z-1856-2021 Class II — Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also use (April 14, 2021)
  • Z-1857-2021 Class II — Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is als (April 14, 2021)
  • Z-1858-2021 Class II — E3800 PC Units (spare parts) (April 14, 2021)
  • Z-1683-2021 Class II — PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyt (March 26, 2021)
  • Z-2493-2020 Class II — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393- (May 26, 2020)
  • Z-2494-2020 Class II — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393- (May 26, 2020)

FDA data resources