Z-1858-2021 Class II Ongoing
FDA device recall Z-1858-2021 was initiated by Radiometer Medical ApS on April 14, 2021 and is designated Class II. Reason for recall: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. The recall status is ongoing. Affected quantity: Total 965 PC units World-wide (only 35 units in the U.S.).
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 965 PC units World-wide (only 35 units in the U.S.)
Product Description
Reason for Recall
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.