ABL800 analyzer — Class II medical device recall Z-0682-2019
Terminated recall by Radiometer America Inc, reported 2019-01-02, distributed nationwide. The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence o
| Recall number | Z-0682-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Brea, CA, United States |
| Recall initiated | 2018-07-03 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2023-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,131 analyzers |
| Reason classes | software |
| Model numbers | 393-800, 393-801, ABL800 |
Product
ABL800 analyzer, model numbers 393-800 and 393-801.
Reason for recall
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
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-0682-2019. 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.