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:3/27/2017)... ... March 27, 2017 , ... Sodium determination is consistently becoming ... require expert user knowledge. In a live webinar on April 11th and October ... highly accurate, determination of sodium. , It has long been known that too ...
(Date:3/27/2017)... CA (PRWEB) , ... March 27, 2017 , ... ... has entered a settlement agreement to resolve the pending litigation between itself and ... for the District of Utah). , “I am thrilled to announce that we ...
(Date:3/27/2017)... RICHEY, Fla. (PRWEB) , ... March 27, 2017 ... ... drug overdose deaths soared 167%,(1) with opioids alone responsible for over 33,000 of ... Kevin McCarty has sponsored Assembly Bill (AB) 1512, which proposes a tax on ...
(Date:3/27/2017)... ... , ... Harris Communications, Inc., a leading provider of assistive technology for ... Deaf Seniors of America Conference, April 4-7 at the Hotel Westin Galleria in Houston. ... staff from Harris Communications and to try out the newest assistive devices available to ...
(Date:3/25/2017)... ... March 25, 2017 , ... Getting earned media coverage meaningful for Garden Media ... All through the year, Garden Media aims to provide material helpful to clients’ goals ... pitching client’s key messages to gain coveted media placements, Garden Media wows ...
Breaking Medicine News(10 mins):
(Date:3/27/2017)... Therapix Biosciences Ltd. (NASDAQ: ... the development of cannabinoid-based drugs, today announced the ... the United States of 2,000,000 American ... shares of the Company, at a price of ... the underwriters a 45-day over-allotment option to purchase ...
(Date:3/27/2017)... March 27, 2017  A recent study at Shriners ... freestanding hospitals in the country dedicated to the treatment ... surgery, concluded that the Surfacide Helios ® UV-C ... in reducing bacterial pathogens not killed by the EVS ... at the American Burn Association,s 49th Annual Meeting in ...
(Date:3/27/2017)... March 27, 2017  ImMAGE Biotherapeutics (OTCMKTS: IMMG), an ... passed early toxicology and efficacy studies. The company is ... a specific protein, MAGE A, in an effort to ... After 4 weeks of treatment in ... very little toxicity in a full toxicology report of ...
Breaking Medicine Technology: