FDA Device recall Z-1515-2022
cobas e801 Immunoassay Analyzer
- FDA Device
- Class II
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of cobas e801 Immunoassay Analyzer by Roche Diagnostics Operations, citing software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1515-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-14 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
cobas e801 Immunoassay Analyzer
Reason
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
Identifiers
| code_info | UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1515-2022%22
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