Beckman Coulter, Inc. Ringed DxI Reaction Vessels (RVs) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ringed DxI Reaction Vessels (RVs)
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
UDI: 15099590229979, Catalog Number: 386167, Lot Numbers: L17855111, L17798598, L18046334
Products Sold
UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) due to Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the re. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
A customer letter titled, Urgent Medical Device Recall, dated 06/07/2023, was issued to the impacted consignee via first-class mail and email. The consignee is instructed to discard the product and request a replacement. The consignee is asked to complete the response form and submit to the recalling firm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026