ABL90 FLEX Analyzer — Class II medical device recall Z-1760-2020
Terminated recall by Radiometer Medical ApS, reported 2020-04-29, distributed nationwide. The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally pri
| Recall number | Z-1760-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2020-02-03 |
| Classified | 2020-04-22 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2022-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HR, HU, IN, IT, JP, KR, NL, NO, PL, SE, SG, TR, ZA |
| Quantity | 12,822 units |
| Reason classes | labeling |
| Model numbers | 393-090 |
Product
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Reason for recall
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
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-1760-2020. 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.