PlainRecalls
FDA Devices Moderate Class II Ongoing

Ringed DxI Reaction Vessels (RVs)

Reported: August 2, 2023 Initiated: June 20, 2023 #Z-2237-2023

Product Description

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.

Details

Recalling Firm
Beckman Coulter, Inc.
Units Affected
213 cases of 10,000 RVs (2,130,000 RVs)
Distribution
Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.
Location
Chaska, MN

Frequently Asked Questions

What product was recalled? ▼
Ringed DxI Reaction Vessels (RVs). Recalled by Beckman Coulter, Inc.. Units affected: 213 cases of 10,000 RVs (2,130,000 RVs).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2023. Severity: Moderate. Recall number: Z-2237-2023.

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