FDA Device recall Z-2237-2023
Ringed DxI Reaction Vessels (RVs)
- FDA Device
- Class II
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Ringed DxI Reaction Vessels (RVs) by Beckman Coulter, citing 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 ide….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2237-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-20 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Ringed DxI Reaction Vessels (RVs)
Reason
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.
Identifiers
| code_info | UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2237-2023%22
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