medical Class II Updated 2023-08-02

Beckman Coulter, Inc. recalls Ringed DxI Reaction Vessels (RVs)

Recalled Product

Ringed DxI Reaction Vessels (RVs)


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334
View official government recall

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