Reported Jun 23, 2021 · Ongoing

E3800 PC Units (spare parts)

Radiometer Medical ApS

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj · N/A

Is this the product you have?

  • E3800 PC Units (spare parts)
Lot codes and dates
  • Part number910-414
Amount recalled
Total 965 PC units World-wide (only 35 units in the U.S.)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Radiometer Medical ApS recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.