Class 1 Recall: Abbott Laboratories Inc. ARCHITECT® STAT Troponin-I Immunoassay

Date Recall Initiated:

March 8, 2007

Product:

Abbott ARCHITECT® STAT Troponin-I Immunoassay,
(List #2K41, all lots).

Use:

Doctors use this test in diagnosing damage to the heart and/or a heart attack (myocardial infarction) in people who have had chest pain.

A troponin I test is usually ordered, along with other cardiac tests, in the hospital to determine if a patient has had a heart attack or damage to the heart muscle. The test is conducted using a sample of the patient’s blood. The results of troponin I test should be used with additional medical tests and medical information including other cardiac markers, electrocardiogram (ECG), medical observations, and symptoms to determine if the patient has had a heart attack, or is experiencing chest pain due to other causes.

Recalling Firm:

Abbott Laboratories Inc.
Firm: 100 Abbott Park Road
Abbott Park, IL 60064

Manufacturing Firm:

Thermo Fisher Diagnostics
8365 Valley Pike
P.O. Box 307
Middletown, VA 22645

Reason for Recall:

A small number of clinical laboratories reported inconsistent or invalid test results at very low levels of troponin-I (i.e., less then 0.1ng/mL). The assay may report falsely elevated or falsely decreased results at and near this low level, which may impact patient treatment. A falsely low troponin result may cause a doctor to send a patient home with heart muscle damage or early signs of a severe heat attack which may lead to worsening of the patient’s condition, delay in treatment and potentially death. A falsely high troponin result may lead to unnecessary surgery, which carries its own risks of harm to patients.

Patients should contact their doctor if they have any concerns about their troponin-I test results.

Public Contact:

Clinical laboratories can call Abbott Customer Support at 1-877-422-2688.

FDA District:

Chicago

FDA Comments:

Abbott sent a Product Correction letter on 3/8/07 followed by an updated letter on 5/29/07 to all clinical laboratories who received reagent lots in the last 12 months. Laboratories are being advised to be cautious when reporting results at or near the lower limit of detection and to advise physicians ordering the tests about the possibility of inaccurate results at those levels.

For more information about this recall, please see the company’s press release at:
http://www.abbott.com/global/url/pressRelease/ en_US/60.5:5/Press_Release_0470.htm

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular problem occur, use of the affected product may cause serious injury or death if the problem is not corrected. Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500
  available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD
  20852-9787
• FAX: 1-800-FDA-0178