Events

Recall of Access Progesterone Assay, Part number 33550.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    25392
  • Event Risk Class
    Class 2
  • Event Number
    Z-0494-03
  • Event Initiated Date
    2002-12-06
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25729
  • 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
    Radioimmunoassay, Progesterone - Product Code JLS
  • Reason
    Primary tube sampling issue may cause false low results.
  • Action
    Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.

Device

Access Progesterone Assay, Part number 33550.

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 South Kraemer Blvd W 337, Brea CA 92822
  • Source
    USFDA