UniCel DxH800 — Class II medical device recall Z-0236-2018
Terminated recall by Beckman Coulter Inc., reported 2017-12-20, distributed in AR, CA, HI, MD, OH, WA. The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open
| Recall number | Z-0236-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-11-03 |
| Classified | 2017-12-13 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2018-06-19 |
| Distributed | AR, CA, HI, MD, OH, WA |
| Countries outside the US | CA, JP |
| Quantity | 15 units |
| Serial numbers | 629029, AS23151, AS36312, AS49422, AT02044, AT06095, AT06096, AT40563, AT50679, AW05066, AW05072, AW05080, AW10154, AW10161, AZ34447, AZ34449, B24802 |
| Model numbers | 629029, B24802 |
Product
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Reason for recall
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
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-0236-2018. 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.