Navigation Links
Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test
Date:5/6/2009

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 www.fda.gov/medwatch.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... Los Angeles-based weight loss ... WE TV’s “Mama June: From Not to Hot,” which will begin airing on February ... Shannon, known to millions from the 2012 reality television series, “Here Comes Honey Boo ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Dr. David ... in Henderson, NV 89052. Dr. Mahon was named a 2017 Top Patient Rated ... is an online directory that recognizes local physicians and dentists who have earned ...
(Date:2/23/2017)... ... February 23, 2017 , ... The Center for ... Island Consortium for Autism Research and Treatment (RI-CART) and Cinemaworld to present Sensory ... disorder (ASD) to see films in an environment that accommodates their unique needs. ...
(Date:2/23/2017)... ... February 23, 2017 , ... HealthPostures, the desk for ... expert sit stand solutions representative to the Minneapolis Home and Garden Show which is ... event that is garnering national attention is the Minneapolis Convention Center. , From ...
(Date:2/22/2017)... ... February 22, 2017 , ... Gevir, a New Zealand-based company ... announced its products are coming soon to Amazon.com, the world’s largest online retailer. ... a means to develop an effective natural treatment for Shelley’s Multiple Sclerosis, which she’d ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)...  Cogentix Medical, Inc. (NASDAQ: CGNT), a medical device ... for the urology market, will release financial results for ... 2016 before the market open on Thursday, March 9, ... conference call and webcast to discuss its financial results ... 11:00 a.m. Eastern Time (10:00 a.m. Central Time). ...
(Date:2/23/2017)... 23, 2017 Research and Markets has announced ... Strategies - 2016" report to their offering. ... The latest research Oesophageal Cancer ... and benchmarks in the global Oesophageal Cancer market. The ... are the key drugs marketed for Oesophageal Cancer and their clinical ...
(Date:2/23/2017)... , February 23, 2017 ... Market by Product (X-ray Imaging Digital, Analog), MRI (Closed, ... (OB/GYN, MSK, Cardiology, Oncology), End User (Hospitals, Imaging Centers) ... report studies the global market over the forecast period ... reach ~USD 36.43 Billion by 2021, at a CAGR ...
Breaking Medicine Technology: