BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.

    Recall: Z-1887-2017 · Initiated February 21, 2017

    Recall

    Recall Number
    Z-1887-2017
    Event Number
    76551
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000136573
    Product Code
    LEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 21, 2017
    Terminated
    June 19, 2019
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101

    Description

    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.

    Reason

    Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.

    Action

    Ortho Clinical Diagnostics sent an IMPORTANT PRODUCT CORRECTION NOTIFICATION letter dated February 21, 2017, was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected VITROS Chemistry Products VANC Reagent lots to inform them of the potential for biased results and to request that they immediately discontinue use of this product. Foreign affiliates were informed by e-mail on February 21, 2017, of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. The communication instructed customer to immediately discontinue use of the affected product. In order to minimize the disruption to the laboratory, the communication also provided the instructions for testing using the affected VANC lots until replacement product was received. If you have any further questions, please contact our OrthoCare Technical Solutions Ctr. at 1(800) 421-3311. For further questions regarding this recall, please call (908) 218-8776.

    Distribution

    Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela.

    Quantity

    US: 2740; OUS: 616