ABL800 FLEX — Class II medical device recall Z-1684-2020
Terminated recall by Radiometer Medical ApS, reported 2020-04-15, distributed nationwide. Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accessio
| Recall number | Z-1684-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2020-03-10 |
| Classified | 2020-04-08 |
| Reported by FDA | 2020-04-15 |
| Terminated | 2022-10-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HR, HU, IT, NO, PL, RU, SE, SG, TR, ZA |
| Quantity | 3,656 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05700693938011 |
Product
ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) In vitro testing of samples of expired air for the parameters pO2 and pCO2 In vitro testing of pleura samples for the pH parameter.0693938004 and 393-801/05700693938011 - Product Usage:
Reason for recall
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss 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-1684-2020. 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.