Z-1321-2022Class II

ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

Name: Z-1321-2022 ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Creator: Radiometer Medical ApS
Published: 2022-05-18
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2022-05-18 / Open, Classified / root cause: software

FDA source

Radiometer Medical ApS began a recall of ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 on 2022-05-18. FDA classified it as Class II and gives the reason as "There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1321-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-18
Posted: 2022-07-01
Recalling firm: Radiometer Medical ApS
Product: ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Root cause tag: software
FDA root cause: Software design
Action: 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]).
Quantity in commerce: 1489 analyzers
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1321-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-01

Product code CHL

K041874Class IIAbl800 FlexRadiometer Medical Aps / cleared 2004-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)