Events

Recall of Clnitest

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions Diagnostics.

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
    47384
  • Event Risk Class
    Class 2
  • Event Number
    Z-1715-2008
  • Event Initiated Date
    2008-04-04
  • Event Date Posted
    2008-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69382
  • 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
    hCG Cassette Pregnancy Test - Product Code JHI
  • Reason
    False negative hcg results due to decreased sensitivity.
  • Action
    Siemens notified Distributors ( Distributor Bulletin Urgent Field Safety Notice) and end-users (Customer Bulletin Urgent Field Safety Notice) Clinitest hCG Cassette Recall by letter dated 4/3/08. Users are requested to, discontinue use, discard the product, and immediately contact Siemens technical support representative or distributor for replacement cassettes from a different lot. If you have any question or have not received the recall notification, contact your local Siemens Distributor Relations Representative or Siemens Technical Support at 877-229-3711 option 13 then 5.

Device

Clnitest
  • Model / Serial
    Lot 97552 Exp 05/16/08; Lot 97574 Exp 05/17/08
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 2 Edgewater Dr, Norwood MA 02062-4637
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA