Class II — Radiometer Medical ApS
| Recalling firm | RADIOMETER MEDICAL APS |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. |
| Product | ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 |
| Quantity | 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 … |
| Initiated | 2022-05-18 |
| Classified | 2022-07-01 |
| Recall number | Z-1321-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Radiometer Medical ApS (Z-1321-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90286/
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