FDA Device recall Z-0160-2027
DxU 840m Iris, REF: C76947
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of DxU 840m Iris, REF: C76947 by Beckman Coulter, citing the rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0160-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-12 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Reason
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.
Identifiers
| code_info | Product/UDI-DI: DxU 840m/15099590748654, DxU 850m/15099590748647. All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
Other recalls by Beckman Coulter
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
FDA Device · Class II · 2026-10-14 · Beckman Coulter - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3…
FDA Device · Class II · 2026-10-14 · Beckman Coulter - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter - Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519
FDA Device · Class II · 2026-08-26 · Beckman Coulter
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2027%22
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