BEUDAMED
    FDA Recall Terminated

    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

    Recall: Z-2202-2021 · Initiated July 12, 2021

    Recall

    Recall Number
    Z-2202-2021
    Event Number
    88323
    FEI Number
    1616487
    Product Code
    JIN
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 12, 2021
    Terminated
    March 29, 2022
    Address
    1261 N Main St, Stanbio Laboratory, LP, Boerne, TX, 78006-3014

    Description

    Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

    Reason

    Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

    Action

    On 07/12/2021, the firm sent an "PRODUCT CORRECTION NOTIFICATION" Letter via First Class mail (U.S.) and email (O.U.S.) to inform customers that the Recalling Firm has observed deterioration in the stability of the liquid reagents which has resulted in lower than expected or out of range Quality Control values. Customers are instructed to: 1) Discontinue use of and quarantine any affected product. 2) Only the lot listed in the table provided are affected and customers may continue to use any other lots they may have in their possession. 3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. 4) If customers have forwarded the product to another laboratory, please provide a copy of this letter to them. Provide the name, address and a contact for the laboratory on the Verification Form. 5) Complete and FAX or email the enclosed Verification Form within 10 days to confirm their receipt of this notice. If you have further questions, please contact Technical Support at 1-800-531-5535 ext. 128.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

    Quantity

    3,940 units