BEUDAMED
    FDA Recall Terminated

    HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206

    Recall: Z-2298-2020 · Initiated November 14, 2019

    Recall

    Recall Number
    Z-2298-2020
    Event Number
    85412
    Firm
    Hardy Diagnostics
    FEI Number
    2022807
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 14, 2019
    Posted
    June 9, 2020
    Terminated
    April 28, 2021
    Address
    1430 W McCoy Ln, Santa Maria, CA, 93455-1005

    Description

    HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206

    Reason

    False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

    Action

    On 11/14/2019, the firm sent a notification of recall letter to customers, informing them of the performance issue of the device lot of the breakthrough on firm's differential chromogenic medium. The customers were advised to discard the remaining stock, and notify the Technical Services Department. If the customer would like replacement or credit, contact Technical Services Department or via e-mail at [email protected], or 800-266-2222 option 2 or ext. 5658.

    Distribution

    U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. OUS: British Virgin Islands, Kenya,

    Quantity

    3,580 ea (358 kits, pack of 10 in each)