Radiometer Medical ApS: Medical Device Recall in 2020 - (Recall #: Z-2493-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 26, 2020

Date Posted: July 15, 2020

Recall Number: Z-2493-2020

Event ID: 85700

Reason for Recall:

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

Status: Terminated

Product Quantity: 4,615 units

Code Information:

Software versions 6.19 and below.

Distribution Pattern:

US - AL, AR, AZ, BM, 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 and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated