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Audience: Emergency care managers, hospital risk managers, laboratory services managers
Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health professionals 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. Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
