Ringed DxI Reaction Vessels — Class II medical device recall Z-2237-2023
Ongoing recall by Beckman Coulter, Inc., reported 2023-08-02, distributed nationwide. Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System
| Recall number | Z-2237-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2023-06-20 |
| Classified | 2023-07-26 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | QA |
| UPC / GTIN / UDI-DI | 15099590229979 |
| Lot numbers | L17798598, L17855111, L18046334 |
| Model numbers | 386167 |
Product
Ringed DxI Reaction Vessels (RVs)
Reason for recall
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.
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-2237-2023. 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.