FDA Device recall Z-0085-2021
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
- FDA Device
- Class II
- ongoing
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 by Roche Diagnostics Operations, citing potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the elec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0085-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-08-31 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Reason
Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
Identifiers
| code_info | All units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2021%22
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