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Recall Observatory FDA recall evidence

Device product

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

Z-1856-2021

April 14, 2021

Class II

Product summary

Firm
Radiometer Medical ApS
Event
Event 87870
Status
Ongoing
Classification
Class II
Quantity
Total=3,346 analyzers world-wide (only 2 analyzers within the U.S.)
Official record key
device-enforcement:Z-1856-2021

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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