CLASS II ONGOING Device recall · Reported 23 Jun 2021 · FDA Enforcement Report
E3800 PC Units (spare parts) recalled by Radiometer Medical ApS
Radiometer Medical ApS is recalling E3800 PC Units (spare parts), distributed nationwide in the US. The recall was initiated on 14 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1858-2021
- FDA event ID
- 87870
- Recalling firm
- Radiometer Medical ApS, Bronshoj
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Apr 2021
- FDA classified
- 15 Jun 2021
- Reported
- 23 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Apr 2021 | Recall initiated by company | |
| 15 Jun 2021 | Classified by FDA | +62 days |
| 23 Jun 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Product as listed by the FDA
E3800 PC Units (spare parts)
Where it was distributed
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.
Nationwide AlaskaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Which lots are affected?
Part number: 910-414
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 87870| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Radiometer ABL90 FLEX Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide | |
| CLASS II | Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide |
More recalls from Radiometer Medical ApS
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Radiometer ABL90 Series - Radiometer ABL90 FLEX recalled | Radiometer Medical ApS | Device Malfunction | 49 states |
| Device | CLASS II | Aqure REF 933-599 Software Versions 2.5.2 recalled | Radiometer Medical ApS | Packaging Defects | Nationwide |
| Device | CLASS II | ABL800 Flex Analyzer recalled by Radiometer Medical ApS | Radiometer Medical ApS | Other | Nationwide |
| Device | CLASS II | Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL recalled | Radiometer Medical ApS | Sterility | Nationwide |
| Device | CLASS II | Radiometer ABL90 Flex Plus Analyzer with E3800 PC units recalled | Radiometer Medical ApS | Other | Nationwide |
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