Events

Recall of Single Analyte Urine DAU Control (5 m L

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
    66542
  • Event Risk Class
    Class 3
  • Event Number
    Z-0386-2014
  • Event Initiated Date
    2013-10-03
  • Event Date Posted
    2013-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122570
  • 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 specific control materials - Product Code LAS
  • Reason
    Product catalog # a68825 norbuprenorphine 13 ng/ml level 2 controls gives a decreased concentration reading due to the degradation of the nbup analyte in solution.
  • Action
    Beckman Coulter sent a Manufacturer Field Action Letter dated November 2013, to the one distributor. The letter identified the product the problem and the action needed to be taken by the customer. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. If you have any questions regarding this notice, please contact our Customer Support Center ¿¿ Via our website, http://www.beckmancoulter.com/customersupport/support ¿¿ Via phone, call 1-800-854-3633 in the United States ¿¿ Outside the United States, contact your local Beckman Coulter Representative. We apologize for any inconvenience.

Device

Single Analyte Urine DAU Control (5 m L
  • Model / Serial
    Catalog #A68825, Lot #1307086; Exp. 3/28/2014/
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution in CA.
  • Product Description
    Single Analyte Urine DAU Control (5 m L || Norbuprenorphine, Level II control || For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. || Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. || Manufacturer: || Lin-Zhi International, Inc. || 670 Almanor Ave. || Sunnyvale, CA 94085 || The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine.
  • 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