ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Check against the official notice below — it lists the full affected range.
Radiometer Medical ApS is recalling 1,489 ABL800 Flex Analyzer units (model numbers 393-800 and 393-801) distributed worldwide, including across all U.S. states and multiple countries. The analyzers that are affected contain software versions below V6.19 MR2 and are configured with cNa+, cCa+, and cK+ capabilities. These devices have the potential for sporadic incidents of positive and negative biases in their measurement results.
The recall notice does not specify a remedy or any corrective actions that consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Reason for recall: There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. 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 an Quantity: 1489 analyzers Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.