The Recall Desk
HighFDA (Devices)·Z-1858-2021·Announced 2021-06-23

Medical Device Analyzer Spare Parts Recalled for Internal Clock Defect

Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a functional defect (internal clock issue) with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Radiometer Medical ApS is recalling E3800 PC Units (spare parts) due to an issue with the internal clock of analyzers equipped with these units. These spare parts are components used in medical analyzers.

Approximately 965 E3800 PC Units have been distributed worldwide, with 35 units in the United States. U.S. distribution encompasses all states. International distribution includes Canada, Mexico, and numerous countries throughout Europe, Asia, Africa, the Middle East, and South America.

The recalled product

Product
E3800 PC Units (spare parts)
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Analyzer / Testing Equipment
Hazard
  • clock-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part number: 910-414

Distribution

Distributed nationwide across the United States.

Related recalls

Same category