Events

Recall of NucliSENS Lysis Buffer

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
    78387
  • Event Risk Class
    Class 2
  • Event Number
    Z-0086-2018
  • Event Initiated Date
    2017-10-18
  • 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=159394
  • 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
    General purpose reagent - Product Code PPM
  • Reason
    Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (dbs) samples. this can potentially cause the inhibition of pcr reactions and result in an uninterpretable test result. if using an internal control (ic) in the extraction process the ic could potentially be inhibited as well and invalidate test results.
  • Action
    US customers were notified on 10/18/2017 via letter using 2-day Fed Ex shipment. Instructions included notifying all appropriate personnel in the laboratory or to customers if product was further distributed, refrain from using the affected product, and arrange for replacement of affected product by completing and returning the response form. It also instructed customers to contact and discuss any concerns regarding previously reported results with the appropriate Laboratory Medical Director to determine an appropriate course of action.

Device

NucliSENS Lysis Buffer
  • Model / Serial
    REF 200292, Lot 17022802, Exp Date 01/28/2019  Extended lot for RES 76675
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed domestically to MD, CO, and OH.
  • Product Description
    NucliSENS Lysis Buffer || Extended lot for RES 76675
  • 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