Beckman Coulter, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2237-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Ringed DxI Reaction Vessels (RVs)

Product Classification:

Class II

Date Initiated: June 20, 2023

Date Posted: August 2, 2023

Recall Number: Z-2237-2023

Event ID: 92576

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.

Status: Ongoing

Product Quantity: 213 cases of 10,000 RVs (2,130,000 RVs)

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.

Voluntary or Mandated:

Voluntary: Firm initiated