medical Class II Updated 2020-07-15

Radiometer Medical ApS recalls Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLE

Recalled Product

Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.

Hazard / Issue

Potential risk of patient mix-up on analyzers due to software issues.

Issued by

FDA

Affected States: AL, 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
Lot/Code Info: Software versions 6.19 and below.
View official government recall

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