Z-1856-2021 Class II Ongoing

Recalled by Radiometer Medical ApS — Bronshoj

Recall Details

Product Type
Devices
Report Date
June 23, 2021
Initiation Date
April 14, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Total=3,346 analyzers world-wide (only 2 analyzers within the U.S.)

Product Description

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

Reason for Recall

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

Distribution Pattern

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.

Code Information

Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards