E3800 PC Units (spare parts)
Reported: June 23, 2021 Initiated: April 14, 2021 #Z-1858-2021
Product Description
E3800 PC Units (spare parts)
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 965 PC units World-wide (only 35 units in 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? ▼
E3800 PC Units (spare parts). Recalled by Radiometer Medical ApS. Units affected: Total 965 PC units World-wide (only 35 units in 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-1858-2021.
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