Events

Recall of Device Recall MultiAnalyte Urine 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
    60743
  • Event Risk Class
    Class 2
  • Event Number
    Z-0868-2012
  • Event Initiated Date
    2011-08-23
  • Event Date Posted
    2012-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106374
  • 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
    Calibrators, drug mixture - Product Code DKB
  • Reason
    Multi analyte urine dau cutoff calibrator gives a decreased absorbance reading due to a loss of the bzo (oxazepam) analyte from the solution and may cause false positive readings.
  • Action
    The firm, Lin-Zhi International, Inc., sent a notice by email dated August 23, 2011 to all customers. The notice described the product, problem and actions to be taken. Lin-Zhi will contact the customers to determine whether they want replacement BZO calibrators and controls immediately or if they are willing to wait a minimum of four weeks for a new lot of the Multi-Analyte Urine Cutoff Calibrators. The customers were instructed to contact Lin-Zhi with their replacement request. The notice also stated that the Lin-Zhi has plans to create more stringent QC standards and further R&D; regarding stabilization of this analyte in solution in its calibrators of controls containing BZO. If you have any questions or concerns regarding how this situation is being handled or the outcome, contact Lin-Zhi at (408)732-3856; email: customerservice@lin-zih.com or webpage: www.lin-zhi.com.

Device

Device Recall MultiAnalyte Urine DAU Cutoff Calibrator
  • Model / Serial
    Catalog number 0803; Lot 1101136K3, exp 1/28/13
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
  • Product Description
    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) || For in vitro diagnostic use only. || Lin-Zhi International, Inc.. || 670 Almanor Ave. || Sunnyvale, CA 94085 || intended use: Drug abuse detection.
  • 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