BEUDAMED
    FDA Recall Open, Classified

    Accelerate PhenoTest BC kit REF 10102018

    Recall: Z-0346-2023 · Initiated October 17, 2022

    Recall

    Recall Number
    Z-0346-2023
    Event Number
    91075
    Firm
    Accelerate Diagnostics Inc
    FEI Number
    3010671651
    Product Code
    PRH
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    October 17, 2022
    Posted
    December 6, 2022
    Address
    3950 S Country Club Rd, Ste 470, Tucson, AZ, 85714-2240

    Description

    Accelerate PhenoTest BC kit REF 10102018

    Reason

    Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

    Action

    On 11/04/2022, the firm communicated an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that the firm has become aware of complaints concerning false positive identification results for Staphylococcus aureus and Streptococcus spp. when using the Accerlerate PhenoTest BC kits. Customer are instructed to: (1) Share this customer notification with all who need to be made aware within their organization. (2) Appropriately destroy all affected Accelerate PhenoTest BC kits by defacing all labeling and disposing in accordance with site biohazard or waste policies and procedure. (3) Complete the Recall Response Form and return it to Accelerate Diagnostics. (4) Retrospectively review runs from affected lots, specifically those runs with positive identification results for either Staphylococcus aureus or Streptococcus spp. Follow their institutional policies and processes to review prior patient results related to the described issue. (5) Continue to report all technical issues through Accelerate Technical Support. Contact for Questions: NA Customer Service & Technical Support Toll free: +1 (888) 586 2939 opt. 4 Direct: +1 (520) 365 3100 Email: [email protected]

    Distribution

    U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV. O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates

    Quantity

    7,160 kits