Events

Recall of Barbiturate Enzyme Immunoassay

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
    60750
  • Event Risk Class
    Class 2
  • Event Number
    Z-0846-2012
  • Event Initiated Date
    2011-09-08
  • Event Date Posted
    2012-01-24
  • 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=106392
  • 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, barbiturate - Product Code DIS
  • Reason
    Catalog #0140 and 0141 barbiturate eia small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.
  • Action
    Lin-Zhi sent a letter via e-mail dated September 8, 2011 to customers with information regarding the recall. The e-mail identified the product description, lot number, description of nonconformity and corrective actions to be taken. Each customer and distributor was then contacted by regulatory affairs personnel by phone on September 9, 2011 or September 12, 2011. Customers and distributors were contacted to determined whether they wanted a replacement of the affected product. Customers that wished for replacements of the affected product was asked to correctly dispose of the product with the lot numbers listed. For questions or concern call 408-732-3856.

Device

Barbiturate Enzyme Immunoassay
  • Model / Serial
    Large Kits Catalog number 0141, lot # 1105052, exp 11/25/12; small kits catalog number 0140, lot # 1105053, exp 11/25/12.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.
  • Product Description
    Barbiturate Enzyme Immunoassay; R1 || Antibody/Substrate Reagent (5000 tests and 500 tests); || Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. || and Barbiturate Enzyme Immunoassay R2; || Enzyme Conjugate Reagent (5000 tests and 500 test packaging); || Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. || For in-vitro diagnostic use only. || Lin-Zhi International Inc. || 670 Almanor Ave., || Sunnyvale, CA 94085 || Product Usage: Drug testing
  • 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