FDA Device recall Z-1444-2020
Elecsys CA 19-9, Cat
- FDA Device
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of Elecsys CA 19-9, Cat by Roche Diagnostics Operations, citing 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 clini….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1444-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-07 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Reason
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.
Identifiers
| code_info | Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Roche Diagnostics Operations recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1444-2020%22
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