BEUDAMED
    FDA Enforcement Class II Ongoing

    GEM Premier 5000 PAK; Part No. 00055360010.

    Recall: Z-1526-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1526-2026
    Event ID
    98349
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Instrumentation Laboratory
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 18, 2026
    Initiation Date
    January 20, 2026
    Classification Date
    March 10, 2026
    Address
    180 Hartwell Rd, N/A, Bedford, MA, 01730-2443, United States

    Description

    GEM Premier 5000 PAK; Part No. 00055360010.

    Reason

    Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

    Code Info

    Part number: 00055360010; UDI: 08426950807599; Lots No.: 251023N, 251024I, 251103I, 251117T, 251118B, 251120R, 251124O, 251126E, 251201X, 251202E, 251202G, 251203H, 251204O, 251205L, 251205N, 251208C, 251208G, 251209Q, 251209R, 251215Y, 251217V, 251218AA, 251218T, 251219M, 251222AE, 251222AF, 251222AG, 251222E, 251222F, 251223R, 251223S, 251229H, 251229J, 251229U, 251230A, 251231E, 251231K, 251231L.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.

    Quantity

    1,225 units