cobas p 501 post-analytical units — Class III medical device recall Z-1927-2019
Terminated recall by Roche Diagnostics Corporation, reported 2019-07-10, distributed nationwide. There is a potential for the tray input flap on the post analytical units to become loose, potentially detachi
| Recall number | Z-1927-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2019-04-04 |
| Classified | 2019-07-02 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | device malfunction |
| Serial numbers | 1001 |
| Model numbers | 05158494001 |
Product
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Reason for recall
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
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-1927-2019. 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.