Product Wiki · Recalls · U.S. FDA — Device Enforcement

E3800 PC Units (spare parts) — recall Z-1858-2021

U.S. FDA — Device Enforcement · Denmark · 2021-04-14 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1858-2021
Date of alert
2021-04-14
Country / jurisdiction
Denmark
Risk level
Class II
Risk type
recall
Brand
Radiometer Medical ApS
Product category
device
Product type
Devices
Reported risk: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.