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:1/19/2017)... , ... January 19, 2017 , ... ... a medical capacity this year. Drs. Alexander Paziotopoulos, Andrew Petersen and Trish Henrie-Barrus ... condensed version of the clinic’s leading recovery program. , “We know it’s ...
(Date:1/19/2017)... ... January 19, 2017 , ... Bio-Optronics Inc. is ... modern CTMS workflow designed to seamlessly integrate and streamline the way researchers prepare ... single page, maximizing usability and improving efficiency significantly for users – a first ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... panel system. , The Tranquility privacy panel system was designed to deliver ... Tranquility panels help reduce noise and provide the visual privacy required to maintain ...
(Date:1/19/2017)... ... 19, 2017 , ... Rountree Brady Insurance Agency, a Savannah ... eastern Georgia, is embarking on a charity effort to raise awareness and gather ... every year than anything else, yet risk factors associated with heart disease are ...
(Date:1/19/2017)... ... 2017 , ... Attorney Robert “RC” Pate , founder of The Law ... Triumph Over Kid Cancer foundation. Each year, 175,000 children are diagnosed with pediatric cancers. ... the effect of the critical funding gap for research into pediatric cancer research. From ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... January 18, 2017 , , Marks E-QURE ... distribution agreement, following similar agreements in Israel ... Wound care is $2 5 billion ... E-QURE Corp. (OTCQB: EQUR), a leader in medical devices for the treatment of ... Médica Equipos Médicos S.A.S. (TeckMedica) in Colombia for the ...
(Date:1/19/2017)... 18, 2017   Synthetic Biologics, Inc. ... therapeutics designed to preserve the microbiome to protect ... plans to initiate a Phase 2b/3 adaptive pivotal ... lovastatin lactone designed to reduce methane production by ... gut to treat the underlying cause of irritable ...
(Date:1/18/2017)... PAUL, Minn. , Jan. 18, 2017 /PRNewswire-USNewswire/ ... developer of medical devices using neuroblocking technology to ... today announced the pricing of an underwritten public ... million, prior to deducting underwriting discounts and commissions ... The offering is comprised of Class A Units, ...
Breaking Medicine Technology: