FDA Device recall Z-2138-2020
ABL90 FLEX PLUS, model no. 393-02
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of ABL90 FLEX PLUS, model no. 393-02 by Radiometer Medical Aps, citing 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 ligh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2138-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-21 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Radiometer Medical Aps |
| Distribution | US |
Product
ABL90 FLEX PLUS, model no. 393-02; 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
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.
Identifiers
| code_info | ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2020%22
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