Events

Recall of Device Recall i STAT

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

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
    35513
  • Event Risk Class
    Class 2
  • Event Number
    Z-1171-06
  • Event Initiated Date
    2006-05-24
  • Event Date Posted
    2006-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46293
  • 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
    Blood Gas Panel reagents - Product Code JGS
  • Reason
    Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained.
  • Action
    Recall letters were sent out via federal express and email notification was sent electronically with instructions as attachments during the period of 5/8/2006 through 6/7/2006 to include stop useage, and hold for replacement.

Device

Device Recall i STAT
  • Model / Serial
    Lot Number -- Expiration Date:  U06024B -- exp. date 09/14/06; U06037C -- exp. date 09/28/06; U06062A -- exp. date 10/28/06; U06063 -- exp. date 10/28/06.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide ---There is only one US customer for these lots. The rest are international customers (Germany, Turkey, Hong Kong, Japan, Canada). There are no government accounts.
  • Product Description
    i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. || i-STAT Catalog Number -- 220300; || Abbott List Number (US and Canada)-- 06F01-01; || Abbott List Number (Rest of World) -- 06F01-02.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA