BEUDAMED
    FDA Recall Open, Classified

    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    Recall: Z-1609-2026 · Initiated July 24, 2025

    Recall

    Recall Number
    Z-1609-2026
    Event Number
    98555
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2919016
    Product Code
    LTT
    Status
    Open, Classified
    Root Cause
    Material/Component Contamination
    Initiated
    July 24, 2025
    Posted
    March 20, 2026
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

    Reason

    Due to the likely presence of contamination in well(s).

    Action

    On 07/24/2025, the firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter has received reports that when testing clinical isolates there was no growth observed in Ceftazidime (Caz) 1, 8 and 16 mg/mL wells; however, growth was observed in the 4 mg/mL well with multiple panels from this lot. Upon further investigation, it was confirmed the growth was Bacillus spp. and not the clinical isolates being tested. Customers are instructed to: -Consider reviewing previous Caz antimicrobial test results from this lot for any spot growth detection (e.g., isolates with no growth in in Caz 1, 8 and 16 mg/mL wells and growth in the 4 mg/mL well or if there is an unusual increase in Caz MIC values). -Discontinue use of MicroScan Neg MIC 56 Lot 2026-01-03 For any questions regarding this notice, contact Customer Technical Support: -From our website: http://www.beckmancoulter.com -By phone: call 800 677-7226 option 1 in the United States. If replacement product is needed: -Complete the attached Replacement Order Form and email to [email protected] or fax to (866) 294-7850 OR -Call Client Services at (800) 526-3821

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.

    Quantity

    685 boxes