FDA-Device2023-08-02Class II
Ringed DxI Reaction Vessels (RVs)
Beckman Coulter, Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.
Affected count
213 cases of 10,000 RVs (2,130,000 RVs)
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Ringed DxI Reaction Vessels (RVs)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2023Don't want to check this manually?
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