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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
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
Part of a larger recall action
This product is one of 3 recalled by Radiometer Medical ApS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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