BEUDAMED
    FDA Enforcement Class II Terminated

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    Recall: Z-2552-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2552-2019
    Event ID
    83516
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sentinel CH SpA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 2, 2019
    Initiation Date
    June 28, 2019
    Classification Date
    September 20, 2019
    Termination Date
    July 24, 2020
    Address
    Via Robert Koch 2, Milan, N/A, Italy

    Description

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    Reason

    Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

    Code Info

    Lot Number/UDI: 80553Y600/ (01)00380740136277 (17)190731(10)80553Y600; 80444Y600/ (01)00380740136277 (17)190731(10)80444Y600; 80625Y600/ (01)00380740136277 (17)191130(10)80625Y600; 90224Y600/ (01)0038074013627 (17)200229(10)90224Y600

    Distribution

    Nationwide Foreign: ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BANGLADESH BELARUS BELGIUM BOSNIA AND HERZEGOVI BRAZIL BRUNEI CANADA CHILE COLOMBIA COSTA RICA CROATIA CZECH REPUBLIC DENMARK FAROE ISLANDS FINLAND FRANCE GERMANY GREECE GREENLAND HONG KONG IRELAND ISRAEL ITALY JORDAN KUWAIT LEBANON LUXEMBOURG MALAYSIA MALDIVES MEXICO MOROCCO NETHERLANDS NEW ZEALAND NIGERIA NORWAY OMAN PAKISTAN PANAMA PARAGUAY PHILIPPINES POLAND PORTUGAL PUERTO RICO ROMANIA RWANDA SAUDI ARABIA SLOVAKIA SOUTH AFRICA SPAIN ST. VINCENT SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UAE UNITED KINGDOM URUGUAY

    Quantity

    1217 kits