Date Recall Initiated |
June 7, 2004 |
---|---|
Product: |
VITROS Immunodiagnostic Products Troponin I Reagent Pack Lots 1110, 1130, 2510, and 2530. |
Use: |
This laboratory test is used by laboratory professionals to measure the quantity of cardiac troponin I in human blood to aid in the diagnosis of heart attack. |
Recalling Firm: |
Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626-5101 |
Reason for Recall: |
This laboratory test produces random occurrences of false positive test results which could lead to unnecessary medical procedures. |
Public Contact: |
Sherry L. Phillips Director, Worldwide Compliance Ortho-Clinical Diagnostics 585-453-3728 |
FDA District: |
New York Upstate |
FDA Comment: |
Clinical laboratories were instructed by the firm to stop using the product, discard any remaining material and notify the health care provided who ordered the test. FDA considers that the probability of life threatening consequences is likely to occur by use of these products. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death. |
For additional information on this product recall, see the Ortho-Clinical Diagnostics press release at: http://www.fda.gov/cdrh/recalls/recall-060704-pressrelease.pdf. Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00857.html. Scroll down to "Recalls and Field Corrections: Devices – Class I". |
Updated July 30, 2004
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