BEUDAMED
    FDA Recall Open, Classified

    GEM Premier 5000; Part No. 00055445010 & 00055445011.

    Recall: Z-1543-2026 · Initiated January 20, 2026

    Recall

    Recall Number
    Z-1543-2026
    Event Number
    98349
    Firm
    Instrumentation Laboratory
    FEI Number
    1217183
    Product Code
    CHL
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 20, 2026
    Posted
    March 10, 2026
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443

    Description

    GEM Premier 5000; Part No. 00055445010 & 00055445011.

    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.

    Action

    An URGENT MEDICAL DEVICE CORRECTION notice was sent to consignees on 1/20/26 was sent to consignees. The notice instructs consignees to continue to use affected devices with the provided warmup instructions. Consignees are to inform all laboratory staff of this notification and forward the notification if product was further distributed. A copy of the notification is to be maintained in consignee records. Consignees may contact Werfen Technical Support at 1-800-678-0710 for a replacement if a GEM PAK experiences a Process Control Solution Not Detected error.

    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

    1,989 units