Review of Laboratory Tests Underway in Light of International Recall

As the result of a manufacturer’s international recall for a particular lot of a laboratory product used in a test for the assessment of chest pain, the four Regional Health Authorities (RHAs) in Newfoundland and Labrador are currently reviewing approximately 5,000 laboratory tests.

The product is used in a blood test to determine a patient’s troponin level. This blood test is one of several clinical diagnostic tools used by physicians when a patient presents with chest pain. A patient’s troponin level may be elevated during chest pain due to heart problems and is used in conjunction with patient history, other blood tests, an electrocardiogram (EKG) and a physical exam to assess the patient.

This particular lot of the product has been recalled by its manufacturer due to potential test variability. It was used in some smaller lab sites across the island portion of province from April 2011 until early October 2011 and in Labrador from January 2011 to early October 2011. RHAs immediately discontinued its use when notified of the recall. The incidence of variable results is estimated by the manufacturer to be one in 1,000.

“Our Regional Health Authorities are currently reviewing the impact, if any, that this international recall may have had on patients in this province,” said the Honourable Jerome Kennedy, Minister of Health and Community Services. “At this time, we are told that the likelihood of any potential impact to patients is very remote as this blood test is one step in an extensive assessment a physician would conduct on patients with chest pain.”

Physicians who ordered the test and/or the appropriate clinical chief are in the process of being contacted by the RHAs to review relevant patient records to determine if individual follow-up with patients is required. The RHAs are also preparing letters for patients who were tested using the recalled product and it is expected these letters will go out within the next seven to 10 days. A list of the regional laboratories potentially impacted is attached below.

Individuals who have questions or concerns are encouraged to call the Newfoundland and Labrador HealthLine at 1-888-709-2929 (TTY 1-888-709-3555) or contact their physician.

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Media contact:
Jennifer Tulk
Director of Communications
Department of Health and Community Services
709-729-1377, 699-6524
jennifertulk@gov.nl.ca 

BACKGROUNDER
Regional laboratories potentially impacted

Eastern Health
Bonavista Peninsula Health Centre
Burin Peninsula Health Care Centre
Carbonear General Hospital
Dr. A.A. Wilkinson Memorial Health Centre, Old Perlican
Dr. G.B. Cross Memorial Hospital, Clarenville
Dr. Wm. H. Newhook Community Health Centre, Whitbourne
Grand Bank Community Health Centre
Placentia Health Centre
U.S. Memorial Health Centre, St. Lawrence

Central Health
A.M Guy Memorial Health Centre, Buchans
Baie Verte Peninsula Health Centre
Brookfield/Bonnews Health Centre
Connaigre Peninsula Health Centre, Harbour Breton
Dr. Hugh Twomey Health Centre, Botwood
Fogo Island Health Centre
Lewisporte Laboratory and X-Ray Clinic
Green Bay Health Centre
North Haven Manor, Lewisporte
Notre Dame Bay Memorial Health Centre, Twillingate
St. Alban’s Community Health Centre

Labrador-Grenfell Health
Cartwright Community Clinic
Nain Community Clinic
Natuashish Community Clinic

Western Health
Bonne Bay Health Centre
Calder Health Centre, Burgeo
Dr. Charles LeGrow Health Centre, Port aux Basques
Rufus Guinchard Health Centre, Port Saunders
Sir Thomas Roddick Hospital, Stephenville

2011 10 20             3:10 p.m.