BEUDAMED
    FDA Enforcement Class II 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 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2273-2016
    Event ID
    74355
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 3, 2016
    Initiation Date
    May 18, 2016
    Classification Date
    July 22, 2016
    Termination Date
    June 8, 2018
    Address
    513 Technology Blvd, N/A, Rochester, NY, 14626-3601, United States

    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.

    Code Info

    Lots #s: 0329-0528-8193 (exp. 05/01/2017), 0329-0528-8892 (exp. 06/01/2017), 0329-0528-8192 (exp. 05/01/2017), 0329-0528-8902 (exp. 06/01/2017), 0329-0528-8226 (exp. 05/01/2017), 0329-0528-8928 (exp. 07/01/2017), 0329-0528-8227 (exp. 05/01/2017), 0329-0528-9000 (exp. 07/01/2017), 0329-0528-8359 (exp. 05/01/2017), 0329-0528-8927 (exp. 07/01/2017), 0329-0528-8361 (exp. 05/01/2017), 0329-0528-8965 (exp. 07/01/2017), 0329-0528-8360 (exp. 05/01/2017), 0329-0528-8966 (exp. 07/01/2017), 0329-0528-8324 (exp. 05/01/2017), 0329-0528-9167 (exp. 07/01/2017), 0329-0528-8323 (exp. 05/01/2017), 0329-0528-9171 (exp. 07/01/2017), 0329-0528-8325 (exp. 05/01/2017), 0329-0528-9196 (exp. 07/01/2017), 0329-0528-6999 (exp. 03/01/2017), 0329-0528-9172 (exp. 07/01/2017), 0329-0528-7000 (exp. 03/01/2017), 0329-0528-9177 (exp. 07/01/2017), 0329-0528-6998 (exp. 03/01/2017), 0329-0528-9265 (exp. 07/01/2017), 0329-0528-8903 (exp. 06/01/2017), 0329-0528-9176 (exp. 07/01/2017), 0329-0528-8901 (exp. 06/01/2017), 0329-0528-9264 (exp. 07/01/2017), 0329-0528-8893 (exp. 06/01/2017), 0329-0528-9368 (exp. 07/01/2017), 0329-0528-8891 (exp. 06/01/2017), 0329-0528-9369 (exp. 07/01/2017).

    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