FDA Recall’s Biosite Triage Cardiac Panel
May 10, 2009 - Biosite and the FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by as an aid in the diagnosis of a heart attack (myocardial infarction).
The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have.
The effected lot number is W44467B, shipped as 25 individually pouched devices per kit box, and were distributed from Jan. 24 through Feb. 17. On April 27 the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.
For more information: www.fda.gov/medwatch/safety/2009/safety09.htm#Panel
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