Beckman Coulter recalls Ringed DxI Reaction Vessels (RVs) from specific lots due to potential false elevated test results in sensitive immunoassays. Affected units may cause inaccurate results for tests like hsTnI and p2PSA.
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.
Beckman Coulter is recalling certain Ringed DxI Reaction Vessels (RVs) used in their DxI Immunoassay System because some batches have rough surfaces that can cause false high test results. This could lead to incorrect health assessments for specific tests.
The recalled RVs have a rough interior surface from a manufacturing defect that increases relative light units (RLU). This can cause false high results in certain immunoassay tests, particularly sandwich assays such as hsTnI and p2PSA.
Users of Beckman Coulter's DxI Immunoassay System (600, 800 series) with the specific lot numbers listed in the recall may be affected. Those running sensitive tests like hsTnI or p2PSA are most at risk of inaccurate results.
Check for the lot numbers L17855111, L17798598, or L18046334 on the RVs. The product has a unique identifier (UDI) 15099590229979 and catalog number 386167.
Look for the lot numbers L17855111, L17798598, or L18046334 on the Ringed DxI Reaction Vessels.
Tests like hsTnI and p2PSA, which are sandwich assays, may show falsely elevated results due to the rough interior surface of the recalled RVs.
Check for the lot numbers L17855111, L17798598, or L18046334 on the RVs. The product also has a unique identifier (UDI) 15099590229979 and catalog number 386167.
The recall does not specify a remedy, so contact Beckman Coulter directly for guidance on next steps.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2237-2023 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2237-2023 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
