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Medical Device Recalls
Class I Recall: Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack

See Related Information
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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