# FDA recall Z-1858-2021

> **Radiometer Medical ApS** · Class II · device recall initiated 2021-04-14.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1858-2021
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-14
- **Report date:** 2021-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1858-2021

## Citation

> AI Analytics. FDA recall Z-1858-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1858-2021. Source: US FDA. Licensed CC0.

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