Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Ortho-Clinical Diagnostics notified healthcare professionals of a
Class I recall of four lots of the VITROS Troponin I Reagent Pack, a
laboratory test used by professionals to measure the quantity of cardiac
troponin I in human blood to aid in the diagnosis of heart attack. The
recall was initiated due to random occurrences of false positive test
results which could lead to unnecessary medical procedures. Clinical
laboratories were instructed by the firm to stop using the product, discard
any remaining material and notify the health care provider who ordered the
test. FDA considers that the probability of life threatening consequences is
likely to occur by use of these products.
Read the MedWatch 2004 safety summary, including a link to the FDA recall
notice, at:
http://www.fda.gov/medwatch/SAFETY/...ty04.htm#VITROS
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FDA and Ortho-Clinical Diagnostics notified healthcare professionals of a
Class I recall of four lots of the VITROS Troponin I Reagent Pack, a
laboratory test used by professionals to measure the quantity of cardiac
troponin I in human blood to aid in the diagnosis of heart attack. The
recall was initiated due to random occurrences of false positive test
results which could lead to unnecessary medical procedures. Clinical
laboratories were instructed by the firm to stop using the product, discard
any remaining material and notify the health care provider who ordered the
test. FDA considers that the probability of life threatening consequences is
likely to occur by use of these products.
Read the MedWatch 2004 safety summary, including a link to the FDA recall
notice, at:
http://www.fda.gov/medwatch/SAFETY/...ty04.htm#VITROS
--------
Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to http://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
This is an automated message delivery system -- replying to this message will not reach MedWatch staff. If you have comments or questions about MedWatch or this e-mail, please contact us through our comments & feedback web page, http://www.fda.gov/medwatch/feedback.htm
