Events

Recall of Device Recall Fetal Cell Stain Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Simmler 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
    25233
  • Event Risk Class
    Class 2
  • Event Number
    Z-0653-03
  • Event Initiated Date
    2002-12-12
  • Event Date Posted
    2003-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25434
  • 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
  • Reason
    Fixing solution bottles are labeled as buffering solution.
  • Action
    Recall letters dated 12/12/02 were issued via regular mail on 12/18/02 requesting the customer to examine the contents of the kit. If mislabeled bottles are found, they were instructed to return the kit.

Device

Device Recall Fetal Cell Stain Kit
  • Model / Serial
    Lot #92558, Exp. March, 2004
  • Distribution
    Distribution was made to hospitals and distributors nationwide. Foreign distribution was made to hospitals in Canada. Military distribution was made to hospitals in KY, OH, and Japan.
  • Product Description
    Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution (Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast Green). The responsible firm on the label is Simmler, Inc., St. Louis, MO.
  • Manufacturer
    Simmler Inc

Manufacturer

Simmler Inc
  • Manufacturer Address
    Simmler Inc, 4156 Hoffmeister, St Louis MO 63125
  • Source
    USFDA