Ortho-Clinical Diagnostics VITROS® Immunodiagnostic Products Signal Reagent
Class 1 Recall
|March 28, 2006|
VITROS® Immunodiagnostic Products Signal Reagent, Lot 8350, catalog #107 2693
This reagent is a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy.
|Reason for Recall:|
A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests.
Judy M. Strzepek
New York Downstate
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
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