Ringed DxI Reaction Vessels (RVs)
This recall is currently active, issued July 26, 2023. It was issued by Beckman Coulter, Inc..
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- June 20, 2023
- Posted
- July 26, 2023
- Recall Number
- Z-2237-2023
- Quantity
- 213 cases of 10,000 RVs (2,130,000 RVs)
- Firm Location
- Chaska, MN
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334
Root Cause
Under Investigation by firm
Action Taken
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.