Events

Recall of Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lin-Zhi International 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
    67607
  • Event Risk Class
    Class 3
  • Event Number
    Z-1270-2014
  • Event Initiated Date
    2014-02-18
  • Event Date Posted
    2014-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125829
  • 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
    Enzyme immunoassay, opiates - Product Code DJG
  • Reason
    Customer reported that the synchron nbup cutoff calibrator (10 ng/ml) could not be qualified through quality control testing. the cutoff calibrator was recovering at a concentration close to the nbup control level 1 (7 ng/ml).
  • Action
    Lin-Zhi International sent a Recall letter dated February 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters acknowledge that Lin Zhi was notified by the customer that the product could not be qualified and that this was confirmed by Lin-Zhi internal testing. Letters request that the distributor notify all customers of the situation and ask them to destroy any remaining product from the affected lots. the root cause is identified and letters also state that a corrective action has been implemented to prevent future problems. Questions may be directed to Lin Zhi International at 408-732-3856.

Device

Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator
  • Model / Serial
    Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including CA.
  • Product Description
    Single Analyte DAU Calibrator (5 mL) || Norbuprenorphine: Cutoff Calibrator; || IVD - for in vitro diagnostic use only; || Lin-Zhi International || Sunnyvale, CA || The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
  • Manufacturer
    Lin-Zhi International Inc

Manufacturer

Lin-Zhi International Inc
  • Manufacturer Address
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • Manufacturer Parent Company (2017)
    Lin-Zhi International Inc.
  • Source
    USFDA