Navigation Links
Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test

SAN DIEGO, May 6 /PRNewswire/ -- Biosite Incorporated has initiated a voluntary, nationwide recall of one lot of Triage(R) Cardiac Panel. The test is used by healthcare professionals as an aid in the diagnosis of myocardial infarction (heart attack). The product has been recalled due to reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I and myoglobin on the affected lot. Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I and myoglobin. A root cause investigation has been initiated.

The recall is limited to the Triage(R) Cardiac Panel, Catalog No. 97000HS, Lot #W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.

Biosite Incorporated has reported the action to the U.S. Food and Drug Administration.

As is noted in the package insert, the results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction and should be evaluated in the context of all the clinical and laboratory data available.

Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week)

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

SOURCE Biosite Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Abbey Spanier Rodd & Abrams, LLP, Announces Class Action Lawsuit on Behalf of Sequenom, Incorporated Shareholders
2. Accuray Incorporated to Report Financial Results for Third Quarter Fiscal Year 2009
3. Aflac Incorporated To Present at the Raymond James 30th Annual Institutional Investors Conference
4. Aflac Incorporated Provides Added Detail on Perpetual Debenture Holdings
5. Aflac Incorporated Announces Fourth Quarter Results, Sees 2008 RBC Ratio Above 450%, Affirms 2009 Operating EPS Target
6. Aflac Incorporated To Release Fourth Quarter Results on February 2, 2009
7. Accuray Incorporated to Present at 11th Annual Needham Growth Stock Conference
8. Aflac Incorporated To Present at the Goldman Sachs U.S. Financial Services Conference 2008
9. Accuray Incorporated to Present at 20th Annual Piper Jaffray Health Care Conference
10. Vertrue Incorporated Gives Tips on How to Hold a Health Fair
11. Accuray Incorporated Ranked Fifth in Deloittes Technology Fast 50 Program for Silicon Valley Scientific/Medical Equipment, and Biotechnology Companies
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted ... in Chicago, IL, UV Angel is evaluating the efficacy of its product and its ... units (totaling 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, ...
(Date:11/25/2015)... LOUIS, Missouri (PRWEB) , ... November 25, 2015 ... ... Project HEAL, will provide scholarships for people struggling with eating disorders as a ... Proceeds from the second annual event, held at Fox Run Golf Club in ...
(Date:11/25/2015)... ... November 25, 2015 , ... Privately owned Contract Development ... expansion of its current state of the art research, development and manufacturing facility ... increase its manufacturing capacity as well as to support its clients’ growing research ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... Sclerosis Complex (TSC), as well as raising public awareness of the disorder while ... it—presented a third donation of $35,000 to bolster progress at the Tuberous Sclerosis ...
(Date:11/25/2015)... ... November 25, 2015 , ... Bunion Bootie , ... early celebration of the early holiday shopping season. Starting Wednesday November 25th, Bunion ... ea). Black Friday promotional pricing is in addition to any automatic discounts applied ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... Nov. 25, 2015 USP 800 applies ... preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician ... The chapter also covers all entities which store, ... hospitals, other healthcare institutions, patient treatment clinics, physicians, ... --> --> What is the ...
(Date:11/25/2015)... Nov. 25, 2015  Mindray Medical ... MR ), a leading developer, ... worldwide, today announced that it will ... of shareholders at the Company,s Hong Kong office ... Prince Edward West Road, Mongkok KL, Hong ...
(Date:11/25/2015)... 2015 Research and Markets ( ) ... - Global Forecast to 2020" report to their ... for 37.21% of the total market share in 2014. ... region is projected to growth at the highest CAGR ... primarily to the fast growing water, industrial gas treatment, ...
Breaking Medicine Technology: