Events

Recall of Device Recall H. pylori (polyclonal)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cell Marque Corporation.

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
    77209
  • Event Risk Class
    Class 2
  • Event Number
    Z-2202-2017
  • Event Initiated Date
    2017-05-05
  • Event Date Posted
    2017-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155441
  • 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
    Immunohistochemical assay, Helicobacter pylori - Product Code OWF
  • Reason
    Cell marque has determined the need to issue a product recall after identifying product intended to be sold outside the u.S. was not properly labeled as "for export only" as required by section 801 (e )(1) of the fd&c; act.
  • Action
    Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.

Device

Device Recall H. pylori (polyclonal)
  • Model / Serial
    1.0 ml lot 1611307C, expiry 201 9-03.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
  • Product Description
    H. pylori (polyclonal} || 1.0 mL Catalog number 215A-76; || Hematology - Analyte Specific Reagent || In vitro diagnostic use - Analyte Specific Reagent
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Manufacturer Address
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Manufacturer Parent Company (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA