BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.

    Recall: Z-1490-2014 · Initiated January 29, 2014

    Recall

    Recall Number
    Z-1490-2014
    Event Number
    67509
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305841
    Product Code
    JFY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 29, 2014
    Posted
    April 23, 2014
    Terminated
    May 18, 2018
    Address
    1000 Lee Road, Rochester, NY, 14606

    Description

    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.

    Reason

    Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.

    Action

    Ortho Clinical Diagnostics sent an Urgent Product Correction Notification Letters dated January 29, 2014, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue. Customers were advised to Inspect their inventory to determine if they had VITROS CRSC DT Slides, GEN 82. - To use their current inventory of GEN 82 until the replacement order arrives providing that they have CDM PROM 0167 installed on their system and calibrate using VITROS DT Calibrator Kit, Lot 42. - If product replacement is required, discard their remaining inventory of VITROS CRSC DT Slides, GEN 82 upon receipt of their replacement order. - Complete and return the Confirmation of Receipt Form by February 7, 2014, by fax to 1-888-557-3759 or 1-585-453-04110, or email to: [email protected]. Indicate on the form if they have any inventory of the affected lot that will require replacement. - Forward this information if they have distributed this product outside of your facility. Distributors were also instructed to identify all customers and any other branches who were shipped VITROS CRSC DT Slides, GEN 82 from their facility and send a copy of the Urgent Product Correction Notification Letter to inform them of the issue. Foreign affiliates were informed by e-mail on January 22, 2014, of the issue and instructed to notify their consignees of the issue and required actions.

    Distribution

    Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.

    Quantity

    US: 284 units, Ex-US: 4772 units