E3800 PC Units — Class II medical device recall Z-1858-2021
Ongoing recall by Radiometer Medical ApS, reported 2021-06-23, distributed nationwide. Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
| Recall number | Z-1858-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, Denmark |
| Recall initiated | 2021-04-14 |
| Classified | 2021-06-15 |
| Reported by FDA | 2021-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, CA, CH, CL, CN, CO, CR, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JO, JP, KR, KW, LU, MX, MY, NL, NO, NZ, OM, PE, PH, PL, PT, QA, RO, RS, RU, SA, SE, SG, SK, TR, UY, ZA |
| Model numbers | 910-414 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1858-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.