FDA Device recall Z-1927-2019
cobas p 501 post-analytical units, Part Number 05158494001
- FDA Device
- Class III
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class III recall of cobas p 501 post-analytical units, Part Number 05158494001 by Roche Diagnostics, citing there is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1927-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-04-04 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
Product
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Reason
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Identifiers
| code_info | Serial Numbers - 1001 through 1044 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.