BEUDAMED
    FDA Recall Open, Classified

    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

    Recall: Z-2012-2021 · Initiated April 30, 2021

    Recall

    Recall Number
    Z-2012-2021
    Event Number
    88040
    Firm
    Sentinel CH SpA Via Robert Koch
    FEI Number
    3000303338
    Product Code
    JJX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 30, 2021
    Address
    2 Milan Italy

    Description

    ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001

    Reason

    Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New IFU instructions for handling the product provided to end users.

    Action

    Sentinel notified distributors by email on the 30th April 2021 and provided the letter (FSN) to be forwarded to final end-users. Letter states reason for recall, health risk and action to take: Actions to be taken: 1. In order to use the product properly, please follow the instructions described here below. 2. Fill in all the required fields of the "Receipt of the Safety Notice" and return it to Sentinel Diagnostics; 3. Review the content of this communication with your Medical Director and retain this letter for any future reference. New procedure Take the Control REF 1667001 from the refrigerator. Carefully remove the cap. " Gently remove the stopper to avoid loss of the lyophilized pellet and add exactly 1.0 ml of distilled or deionized water. Replace stopper and gently swirl. " Let to stand for 24 hrs at 2-8C. Swirl gently each vial immediately before use, avoiding foaming. " Take the volume necessary for the scheduled analysis. Recap and store at 2-8 C. Stability after reconstitution: 5 days when stored at 2- 8 C if contamination is avoided and vials are recapped immediately after use. Transmission of this Field Safety Notice: Please forward this notice to all the indivuals in your organization who need to be aware or to any organization/individuals where the potentially affected devices have been transferred. Reference person: If you or any of your customers have any questions regarding this information, please contact your local area Customer Service

    Distribution

    Worldwide distribution - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CANADA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, JORDAN, NEW ZEALAND, POLAND, PORTUGAL, SERBIA, SOUTH AFRICA, SPAIN, SWEDEN, THE NETHERLANDS, TURKEY, U.A.E., UK.

    Quantity

    1898 kits