BEUDAMED
    FDA Recall Terminated

    VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

    Recall: Z-2273-2016 · Initiated May 18, 2016

    Recall

    Recall Number
    Z-2273-2016
    Event Number
    74355
    Firm
    Ortho-Clinical Diagnostics
    FEI Number
    1000305840
    Product Code
    CJY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 18, 2016
    Terminated
    June 8, 2018
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601

    Description

    VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device Identifier No. 10758750009114 or 20758750009111, IVD -- Sales Unit: 300 slides/pack Product Usage: For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms).

    Reason

    Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or the VITROS 5600 Integrated System. An increase in negatively biased calcium results complaints prompted the investigation that identified this product issue.

    Action

    Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION letter dated May 18, 2016 to affected customers. . The letter identified the affected product, problem and actions to be taken. The letter instructed to discontinue use of the affected lot(s) and discard all remaining inventory. Customers were asked to complete and return the Confirmation of Receipt form. For questions contact Customer Technical Services at 1-800-421-3311.

    Distribution

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

    Quantity

    US: 27,625 sales units; Foreign: 4757 sales units