Events

Recall of Device Recall iSTAT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point of Care 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
    36991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0364-2007
  • Event Initiated Date
    2006-12-12
  • Event Date Posted
    2007-01-23
  • 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=49723
  • 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
    prothrombin time test in vitro diagnostic. - Product Code GJS
  • Reason
    Patients treated with the antibiotic cubicin can cause a concentration dependent false prolongation of prothrombin time (pt) and elevation of inr (international normalized ratio) when using the i-stat pt/inr cartridges.
  • Action
    Customers were notified by letter sent by regular mail on 12/13/2006.

Device

Device Recall iSTAT
  • Model / Serial
    Product list #''s 04J50-01 and 04J50-02, catalog # 420200  Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186, N06188,, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206, N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227, N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A, N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263, N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267, N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C, N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282, N06285, N06285B, N06285C, N06290A, N06294, N06294A, N06295, N06298, N06298A, N06298B, N06301A, N06303, N06304, N06308, N06309, N06310A, N06311,
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to hospitals and health care facilities
  • Product Description
    i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. || Ref 04J50-01 || 24 || IVD || Abbott Point of Care Inc. || 104 Windsor Center Drive || East Windsor, NJ 08520 || Product of Canada
  • Manufacturer
    Abbott Point of Care Inc.

Manufacturer

Abbott Point of Care Inc.
  • Manufacturer Address
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA