medical Class II Updated 2022-07-13

Radiometer Medical ApS recalls ABL800 Flex Analyzer Model Numbers 393-800 and 393-801

Recalled Product

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


Hazard / Issue

There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

Issued by

FDA

Distribution: Nationwide (United States)
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
View official government recall

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