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Recall Observatory FDA recall evidence

Device product

Ringed DxI Reaction Vessels (RVs)

Z-2237-2023

June 20, 2023

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 92576
Status
Ongoing
Classification
Class II
Quantity
213 cases of 10,000 RVs (2,130,000 RVs)
Official record key
device-enforcement:Z-2237-2023

Official wording

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.

Code information: UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.