Events

Recall of MultiAnalyte Urine DAU Control (15 mL);

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
    60691
  • Event Risk Class
    Class 2
  • Event Number
    Z-0838-2012
  • Event Initiated Date
    2011-08-05
  • Event Date Posted
    2012-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106237
  • 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
    Drug mixture control materials - Product Code DIF
  • Reason
    Customer complaint investigation found that the multi-analyte urine dau level 2 control was incorrectly labeled and actually contained multi-analyte dau low level calibrators.
  • Action
    Lin Zhi International, Inc. sent a Recall notification letter dated August 5, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to determine whether they wanted credit or a replacement product. The incorrectly labeled product should be disposed of properly. For questions regarding this recall call 408-732-3856.

Device

MultiAnalyte Urine DAU Control (15 mL);
  • Model / Serial
    Catalog # 0808, lot number 1101137, Exp 1/28/2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MA, FL, NC, NH, WA, and IN.
  • Product Description
    Multi-Analyte Urine DAU Control (15 mL); || Level 2, For in-vitro diagnostic use only. || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers.
  • 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