Events

Recall of Device Recall NeoBase Succinylacetone Assay Solution

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer Life and Analytical Sciences, Wallac, OY.

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
    79303
  • Event Risk Class
    Class 2
  • Event Number
    Z-1692-2018
  • Event Initiated Date
    2017-11-02
  • 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=161848
  • 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
    System, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry - Product Code NQL
  • Reason
    There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
  • Action
    Actions to be taken: - Inspect your inventory of the NeoBase Succinylacetone Assay Solution vials for the affected lots. - If you notice leakage or deformed stopper seals, destroy the affected vials according to local instructions and regulations. - Complete the Response Form with the quantity and identity of affected Succinylacetone Assay Solution vials in your inventory. - Return the Response Form to PerkinElmer. - PerkinElmer will replace the quantity of leaking Succinylacetone Assay Solution vials found and destroyed from your inventory

Device

Device Recall NeoBase Succinylacetone Assay Solution
  • Model / Serial
    Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.
  • Product Description
    NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 || (01)06438147295708(17)180531(10)653414 || (01)06438147295708(17)180531(10)653657 || (01)06438147295708(17)180630(10)654923 || (01)06438147295708(17)180630(10)655680 || (01)06438147295708(17)180630(10)655300 || (01)06438147295708(17)180630(10)654924 || (01)06438147295708(17)180831(10)656025 || (01)06438147295708(17)180831(10)657055 || (01)06438147295708(17)180831(10)656170 || (01)06438147295708(17)180831(10)656320 || (01)06438147295708(17)181031(10)657768 || (01)06438147295708(17)181031(10)657513 || (01)06438147295708(17)181031(10)658006
  • Manufacturer
    PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • Manufacturer Address
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA