ABL80-FLEX CO-OX 393-841 Box Label — Class II medical device recall Z-2468-2020
Terminated recall by Radiometer Medical ApS, reported 2020-07-08, distributed nationwide. Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lact
| Recall number | Z-2468-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2020-05-11 |
| Classified | 2020-06-29 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2023-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,981 |
| UPC / GTIN / UDI-DI | 05700693938417 |
| Lot numbers | 393-841, ABL80-FLEX |
| Model numbers | 393-841 |
Product
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Reason for recall
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or 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-2468-2020. 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.