Events

Recall of Device Recall RF Latex Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanbio Laboratory, LP.

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
    79245
  • Event Risk Class
    Class 2
  • Event Number
    Z-1070-2018
  • Event Initiated Date
    2018-02-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161742
  • 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
    System, test, rheumatoid factor - Product Code DHR
  • Reason
    All patient serum samples yield a weakly positive test result.
  • Action
    Recall notification letters were sent to affected consignees on 2/14/2018. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to stop using affected products, quarantine products, and exchange the kit for an unaffected one.

Device

Device Recall RF Latex Reagent
  • Model / Serial
    Lot 21675
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
  • Product Description
    RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) || RF Latex (1156-001, Control# 172224 expiry 2019-12-31) || RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) || Product Usage: || RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
  • Manufacturer
    Stanbio Laboratory, LP

Manufacturer

Stanbio Laboratory, LP
  • Manufacturer Address
    Stanbio Laboratory, LP, 1261 N Main St, Boerne TX 78006-3014
  • Manufacturer Parent Company (2017)
    EKF Diagnostics Holdings Plc
  • Source
    USFDA