Elecsys CA 19-9 — Class II medical device recall Z-1444-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2020-03-11, distributed nationwide. The firm has received an increased number of complaints concerning non-reproducible elevated results ("high fl
| Recall number | Z-1444-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2020-02-07 |
| Classified | 2020-03-05 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2024-05-30 |
| Distributed | Nationwide (US) |
| Quantity | 684 |
| Lot numbers | 416245, 483123 |
| Model numbers | 07027028190 |
Product
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Reason for recall
The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
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-1444-2020. 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.