--- title: "Radiometer Medical ApS Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Radiometer Medical ApS recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/radiometer-medical-aps/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Radiometer Medical ApS recall records **5** reported ongoing 5 records in this archive. Latest source date Mar 21, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Mar 21, 2025 FDA device enforcement ### [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 p...](https://isitonrecall.com/recall/fda-device-z-1659-2025-radiometer-abl90-series-radiometer-abl90-flex-model-number-393-090-radiometer-abl90-series-radiomete/) 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 det... Class II Reported ongoing 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, ... [Official source for Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Ra...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1659-2025%22) May 31, 2024 FDA device enforcement ### [ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa...](https://isitonrecall.com/recall/fda-device-z-2426-2024-abl800-flex-model-numbers-393-800-and-393-801-the-abl800-flex-analyzers-are-intended-for-in-vitro-te/) Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results ... Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, N... [Official source for ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2426-2024%22) Mar 8, 2023 FDA device enforcement ### [AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate...](https://isitonrecall.com/recall/fda-device-z-1394-2023-aqure-ref-933-599-software-versions-2-5-2-2-5-3-2-5-4-2-6-0-2-6-1-the-aqure-system-is-intended-to-le/) Due to potential software issue that may result in patient mix-up information. Class II Reported ongoing Distribution: Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA... [Official source for AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1394-2023%22) May 18, 2022 FDA device enforcement ### [ABL800 Flex Analyzer Model Numbers 393-800 and 393-801](https://isitonrecall.com/recall/fda-device-z-1321-2022-abl800-flex-analyzer-model-numbers-393-800-and-393-801/) There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, ... [Official source for ABL800 Flex Analyzer Model Numbers 393-800 and 393-801](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1321-2022%22) Apr 8, 2022 FDA device enforcement ### [Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE](https://isitonrecall.com/recall/fda-device-z-1115-2022-radiometer-ref-956-552-pic050-arterial-blood-sampler-1-x-2-ml-80-iu-electrolyte-balanced-heparin-not/) Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, ... [Official source for Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced hepa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1115-2022%22) ## Reasons in these listed records - 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 au... - Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples. - Due to potential software issue that may result in patient mix-up information. - There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. These examples come from this result page and are not a ranking of every recall reason. ## Checking Radiometer Medical ApS ### Is there a recall on radiometer medical aps right now? This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Radiometer Medical ApS](https://isitonrecall.com/check/?q=Radiometer%20Medical%20ApS) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)