Events

Recall of Device Recall Gibson Bioscience Blastomyces dermatitidis Antiserum

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gibson Laboratories LLC.

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
    78731
  • Event Risk Class
    Class 2
  • Event Number
    Z-0606-2018
  • Event Initiated Date
    2017-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160239
  • 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
    Antiserum, blastomyces dermatitidis, other - Product Code LSI
  • Reason
    The firm information that the product was reporting false positive results.
  • Action
    On January 20, 2017, the firm sent Urgent Medical Device Recall notification letter and response form to their customers. The letter identified the affected and the reason for the recall. Users are instructed not to use any Blastomyces dermatitidis (catalog # 200265) that they may have in inventory and to quarantine any affected product. Return any affected product per the instructions provided; and, complete and return the attached acknowledgement form. Questions regarding this recall should be directed to Penny Epperson, Quality Manager, at 859-303-5169 or pepperson@gibsonlabs.com.

Device

Device Recall Gibson Bioscience Blastomyces dermatitidis Antiserum
  • Model / Serial
    Lot # 5072543 Exp Date 03/12/2021; UDI : 10634853000039.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of AL, AZ & MS.
  • Product Description
    Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 || Intended for identification of the systemic fungal pathogens.
  • Manufacturer
    Gibson Laboratories LLC

Manufacturer

Gibson Laboratories LLC
  • Manufacturer Address
    Gibson Laboratories LLC, 1040 Manchester St, Lexington KY 40508-2422
  • Manufacturer Parent Company (2017)
    Gibson Laboratories Llc
  • Source
    USFDA