FDA recall Z-2237-2023

Product

Ringed DxI Reaction Vessels (RVs)

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-06-20

Report date

2023-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2023