Recall Z-1659-2025 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer Medical ApS
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.
| Date | Apr 23, 2025 (initiated Mar 21, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | On 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 |
| Quantity | 6275 analyzers |
| Distribution | 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, Bolivi |
| FDA record | Open on fda.gov |