BEUDAMED
    FDA Enforcement Class II Terminated

    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.

    Recall: Z-2169-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2169-2014
    Event ID
    68617
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Molecular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2014
    Initiation Date
    June 19, 2014
    Classification Date
    August 8, 2014
    Termination Date
    February 23, 2016
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    Description

    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.

    Reason

    Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.

    Code Info

    Unique Product Identifier: 04J71-20; Serial Numbers: 56944001, 57026001, 57059001, 57673001

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to: AUSTRALIA AUSTRIA BELGIUM BENIN CAMEROON CHINA ETHIOPIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND ISRAEL ITALY KENYA MALAYSIA MALAWI MALI NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PHILIPPINES POLAND PORTUGAL RUSSIA SENEGAL SINGAPORE SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE UNITED KINGDOM VIETNAM

    Quantity

    1,688,000 reaction vessels