The Recall Desk
HighFDA (Devices)·Z-1857-2021·Announced 2021-06-23

Radiometer ABL90 FLEX PLUS Analyzer Recalled Due to Internal Clock Issue

Radiometer is recalling ABL90 FLEX PLUS Analyzers with E3800 PC units due to an internal clock issue. Approximately 4,135 units are affected worldwide, including 1,277 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 FDA Class II recall involves a medical device with an internal clock malfunction. Because medical devices directly impact patient safety, a device malfunction represents a risk-of-harm situation. Although no illnesses or injuries have been reported, the potential for patient harm from the device failure warrants a High severity rating per the rubric.

Plain-English summary

Radiometer Medical ApS is recalling the ABL90 FLEX PLUS Analyzer with E3800 PC units due to an issue with the internal clock. The E3800 CPU is also used as a spare part.

This recall affects approximately 4,135 analyzers worldwide, of which 1,277 units are in the United States. The affected model is ABL90 FLEX PLUS (393-092) with serial numbers R0214, R0218, or R0223 and onwards.

The recalled product

Product
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Laboratory Analyzer
Hazard
  • clock-malfunction

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)

  • and R0223 onwards

Distribution

Distributed nationwide across the United States.

Related recalls

Same category