FDA Devices Moderate Class II Ongoing

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Reported: June 23, 2021 Initiated: April 14, 2021 #Z-1857-2021

Product Description

Reason for Recall

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Details

Recalling Firm: Radiometer Medical ApS
Units Affected: Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.)
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.
Location: Bronshoj

Frequently Asked Questions

What product was recalled? ▼

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.. Recalled by Radiometer Medical ApS. Units affected: Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.).

Why was this product recalled? ▼

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1857-2021.