BEUDAMED
    FDA Recall Terminated

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    Recall: Z-0740-2020 · Initiated October 14, 2019

    Recall

    Recall Number
    Z-0740-2020
    Event Number
    84123
    Firm
    Ortho Clinical Diagnostics Inc
    FEI Number
    2250051
    Product Code
    KSG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 14, 2019
    Terminated
    November 13, 2020
    Address
    1001 US Highway 202, Raritan, NJ, 08869-1424

    Description

    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.

    Reason

    Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.

    Action

    On August 9, 2019 the firm distributed Urgent Medical Device Recall Communication letters by via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) summarizing the reason as Ortho Clinical Diagnostics determined that VITROS 7% BSA and VITROS Urine Electrolyte Diluent (UED) do not meet the current OAS time of d 7 days when stored on the VITROS 250/350 System in a 2mL cup only. Orthos internal testing compared results from samples diluted with diluent stored on the analyzer versus fresh diluent. When using 7% BSA or UED stored in a 2mL cup for 7 days, the differences in the results vs fresh diluent were >10% for some assays. It explained as a resolution: " The OAS of 7% BSA and UED in 2mL cups has been revised to d24 hours. " Current OAS time remains at d7 days for storage in 5mL and 10 mL bottles. " The Instructions for Use and appropriate User Documentation will be revised at a future date. It instructs them to: - Send the enclosed customer letter to all customers to whom you shipped or know to have a VITROS 250/350 System. Please continue to provide this letter to new customers until the Instructions for Use are updated. - Complete and return the Confirmation of Receipt form by October 22, 2019.

    Distribution

    Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.

    Quantity

    2,573