Events

Recall of Device Recall Mycoplasma IgM ELISA 96 Well K

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Calbiotech 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
    50691
  • Event Risk Class
    Class 2
  • Event Number
    Z-0998-2010
  • Event Initiated Date
    2008-08-27
  • Event Date Posted
    2010-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76378
  • 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 Linked Immunoabsorbent Assay, Mycoplasma Spp. - Product Code LJZ
  • Reason
    The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
  • Action
    Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service. This recall should be carried out to the wholesale level in order to comply with Federal regulations. Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.

Device

Device Recall Mycoplasma IgM ELISA 96 Well K
  • Model / Serial
    Lot Number: MPM2400, MPM2443 and MPM2544
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    FL, and VA
  • Product Description
    Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M || The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
  • Manufacturer
    Calbiotech Inc

Manufacturer

Calbiotech Inc
  • Manufacturer Address
    Calbiotech Inc, 10461 Austin Dr Ste G, Spring Valley CA 91978-1524
  • Source
    USFDA