Z-2237-2023 Class II Ongoing
FDA device recall Z-2237-2023 was initiated by Beckman Coulter, Inc. on June 20, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 213 cases of 10,000 RVs (2,130,000 RVs).
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- June 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 213 cases of 10,000 RVs (2,130,000 RVs)
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.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.
Code Information
UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334