Events

Recall of Device Recall IMMULITE 2000 Vitamin B12 Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diagnostic Products Corp.

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
    31084
  • Event Risk Class
    Class 3
  • Event Number
    Z-0537-05
  • Event Initiated Date
    2005-01-24
  • Event Date Posted
    2005-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37122
  • 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
    Radioassay, Vitamin B12 - Product Code CDD
  • Reason
    A low cps limit was not incorporated in the kit barcode for immulite 2000 vitamin b12 l2kvb 2, 6 kit lot 186 only.
  • Action
    Domestic customers were notified on January 24, 2005, via telephone and strted receiving a fax-back form and a technical Bulletin on January 25, 2005. Foreign consignees were notified via email and/or Fax.

Device

Device Recall IMMULITE 2000 Vitamin B12 Kit
  • Model / Serial
    IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CO, FL, IL, KS, LA, NY, MA, MD, MI, MS, NC, NE, NM, OH, PA, TN, TX, UT, WA, and Australia, Czech Republic, France, Germany, Netherlands, Portugal, Puerto Rico, Sweden, Turkey, UK, Venzuela
  • Product Description
    IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
  • Manufacturer
    Diagnostic Products Corp

Manufacturer

Diagnostic Products Corp
  • Manufacturer Address
    Diagnostic Products Corp, 5210 Pacific Concourse Dr, Los Angeles CA 90045-6900
  • Source
    USFDA