Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLU

FDA device recall Z-1659-2025 · posted 2025-04-23 · Open, Classified

Recall details

Recalling firm

Radiometer Medical ApS

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.

Action taken

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 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).

Root cause

Component design/selection

Status

Open, Classified

Product code

CHL

Quantity affected

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

Date initiated

2025-03-21

Date posted

2025-04-23

Location

Bronshoj, Denmark

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