ABL800 FLEX recallZ-1321-2022 · Radiometer Medical ApS · initiated May 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Radiometer Medical ApS or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
FDA root cause category: Software design
What the company is doing
On May 20, 2022, Radiometer issued a "Urgent: Medical Device Recall" notification to affected consignees via: Email and FedEx 2nd day Mail. Radiometer ask consignees to take the following actions: 1. For the affected micro measuring modes Radiometer kindly requests you to not use results for cNa+. The most efficient way to ensure this is to remove the parameter from the affected modes as per the procedures included within the letter. 2. Please complete the Recall Response Form and return to your Radiometer representative ([email protected]).
Recall details
- Recall number
- Z-1321-2022
- Status
- Open, Classified
- Initiated by the company
- May 18, 2022
- Recalling firm
- Radiometer Medical ApS
- Quantity
- 1489 analyzers
- Product code
- CHL
- FDA submissions
- K041874
- 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, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Bermuda, Canada, Italy, Norway, Austria, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, 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, China, Croatia, Denmark, Iceland, Germany, Spain, Portugal, India, Brunei, Japan, United Kingdom, Ireland, Russia, Hungary, Australia, New Zealand, Tokelau, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong, Mexico, South Korea, Singapore.
Product description
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Code information (models, lots, serial numbers)
All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ; UDI/DI ABL817, ABL827, ABL837: 05700693938011
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ABL800 FLEX 393-800Radiometer Medical ApS · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH2 recalls81 reports
- ABL800 FLEX 393-801Radiometer Medical ApS · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall27 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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