Radiometer ABL90 Series — Class II medical device recall Z-1659-2025
Ongoing recall by Radiometer Medical ApS, reported 2025-04-30, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1
| Recall number | Z-1659-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2025-03-21 |
| Classified | 2025-04-23 |
| Reported by FDA | 2025-04-30 |
| Distributed | AL, AR, AZ, 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, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 6,275 analyzers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05700693930909, 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 and 475 more |
| Model numbers | 393-090, 393-092 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1659-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.