Biosite Incorporated, Triage Cardiac Panel
|April 27, 2009|
Triage Cardiac Panel, Catalog No. 97000HS, Lot #W44467B, shipped as 25 individually pouched devices per kit box. (This recall is limited only to this catalog and lot number).
This product was manufactured only on January 23, 2009 and distributed from January 24, 2009 through February 17, 2009.
|This test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).|
9975 Summers Ridge Road
San Diego, California 92121
Reason for Recall:
|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.|
|Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week).|
On April 27, 2009, the company sent an urgent recall notice with an attached “Customer/Distributor Verification Form” by FAX, email, or direct mail. Customers were:
For more information about this recall, please see the company’s press release.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.