Events

Recall of Device Recall ETEST Ceftriaxone

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BioMerieux SA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77150
  • Event Risk Class
    Class 2
  • Event Number
    Z-2126-2017
  • Event Initiated Date
    2017-01-01
  • Event Date Posted
    2017-05-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155036
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Reason
    Potential performance issue on strain categorization.
  • Action
    Biomerieux sent an Urgent Field Safety Notice dated January 2017, to Laboratory Manager or Laboratory Director. The Notice indicated what actions to take and included a reply form to be returned. Required actions: The following recommendations require your immediate attention to ensure the product will continue to perform per its labeled performance specifications, within its revised shelf-life of twelve (12) months. Product with NO remaining shelf life (after reduction): Identify impacted lots of ETEST¿ Ceftriaxone TXL32 (Ref. 412302, 412303) (lots listed in Table 1 below) which are now expired after shelf-life reduction. Immediately order the replacement products appropriate for your institution. Until replacement product is available Laboratories may continue to use their now expired strips with the following recommendations: Laboratories should continue to follow their current QC procedures for ETEST¿ Ceftriaxone TXL32 (Ref. 412302, 412303) for the lots listed in Table 1 in accordance with CLIA and local regulatory requirements, with a modification to increase the frequency of QC testing to weekly or every day of use if previous QC testing exceeds one week. Laboratories should include in the QC testing the strain N. gonorrhoeae ATCC 49226 (Expected range-MIC: 0.004-0.016 ¿g/mL) defined as the stability indicator for ETEST¿ Ceftriaxone TXL32 (Ref. 412302, 412303). The MIC result for this specific strain must fall in the acceptable range to confirm the validity of the QC test and performance of the ETEST with the clinical isolate. Only report results if all QC is in the acceptable ranges. When replacement product is received, discontinue using and discard impacted ETEST¿ Ceftriaxone TXL32 (Ref. 412302, 412303) (listed in Table 1). Additional actions: Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use

Device

Device Recall ETEST Ceftriaxone
  • Model / Serial
    Ref 412302  1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200, 1004876830, 1005327130; Ref 507058  1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA
  • Product Description
    Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 || ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA