# FDA recall Z-2139-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2019-11-21.

## Product

ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941  - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

## Reason for recall

The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.

## Distribution

Worldwide distribution - US Nationwide. Also distributed OUS.

## Key facts

- **Recall number:** Z-2139-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-21
- **Report date:** 2020-06-03
- **Termination date:** 2024-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2020

## Citation

> AI Analytics. FDA recall Z-2139-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-2139-2020. Source: US FDA. Licensed CC0.

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