Events

Recall of Device Recall Ammonia L3K Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sekisui Diagnostics P.E.I. Inc..

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
    75818
  • Event Risk Class
    Class 2
  • Event Number
    Z-1078-2017
  • Event Initiated Date
    2016-11-29
  • Event Date Posted
    2017-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151386
  • 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
    Enzymatic method, ammonia - Product Code JIF
  • Reason
    Certain lots are showing an atypical decrease in optical density (od) over time, which may result in an impact to performance at the high end of the linear range.
  • Action
    Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K¿ reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK¿ from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email PEIDiagnosticTechnical@sekisui-dx.com.

Device

Device Recall Ammonia L3K Assay
  • Model / Serial
    Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
  • Product Description
    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 || For the IN VITRO quantitative measurement of ammonia concentration in plasma
  • Manufacturer
    Sekisui Diagnostics P.E.I. Inc.

Manufacturer

Sekisui Diagnostics P.E.I. Inc.
  • Manufacturer Address
    Sekisui Diagnostics P.E.I. Inc., 70 Watts Ave, Charlottetown Canada
  • Manufacturer Parent Company (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA