Elecsys Anti-TPO Assay on cobas e analyzers 411 — Class II medical device recall Z-2981-2020
Terminated recall by Roche Diagnostics Operations, Inc., reported 2020-09-23, distributed nationwide. Recent internal verification studies found the current RF interference claim to no longer be met for the assay
| Recall number | Z-2981-2020 |
|---|---|
| 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 | 2020-08-20 |
| Classified | 2020-09-17 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 11,870 reagent |
| Reason classes | potency |
| Model numbers | 06368590190 |
Product
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Reason for recall
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
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-2981-2020. 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.