ABL800 analyzer with FLEXQ module — Class II medical device recall Z-0231-2018
Terminated recall by Radiometer America Inc, reported 2017-12-20, distributed nationwide. Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by th
| Recall number | Z-0231-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2017-10-24 |
| Classified | 2017-12-08 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2023-10-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,749 analyzers |
| Serial numbers | ABL800 |
Product
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters 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. It is also used for in vitro testing of pleura samples for the pH parameter
Reason for recall
Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
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-0231-2018. 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.