ABL90 FLEX — Class II medical device recall Z-2139-2020
Terminated recall by Radiometer Medical ApS, reported 2020-06-03, distributed nationwide. The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the opt
| Recall number | Z-2139-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2019-11-21 |
| Classified | 2020-05-28 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2024-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,233 units |
| Model numbers | 393-090, R0659, R0977 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2139-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.